Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650)

Wael Mbarki; Hajer Bettaieb; Nesrine Souayeh; Idriss Laabidi; Hadhemi Rouis; Soumaya Halouani; Rami Boufarghine; Maha Bouyahia; Rahma Bouhmida; Mariem Ouederni; Anissa Ben Amor; Amal Chermiti; Hadir Laamiri; Amira Lika; Imen Chaibi; Hedhili Oueslati; Najeh Hsayaoui; Chaouki Mbarki

doi:10.1371/journal.pone.0278939

. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939

Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650)

Wael Mbarki ^1,^2,^#, Hajer Bettaieb ^1,^2,^*,^#, Nesrine Souayeh ^1,², Idriss Laabidi ^1,², Hadhemi Rouis ^1,², Soumaya Halouani ^1,², Rami Boufarghine ^1,², Maha Bouyahia ^2,³, Rahma Bouhmida ^2,³, Mariem Ouederni ^2,³, Anissa Ben Amor ^2,⁴, Amal Chermiti ^2,⁴, Hadir Laamiri ^2,⁴, Amira Lika ^2,⁵, Imen Chaibi ^2,⁵, Hedhili Oueslati ^1,², Najeh Hsayaoui ^1,², Chaouki Mbarki ^1,^2,^#

Editor: Antonio Simone Laganà⁶

PMCID: PMC9754295 PMID: 36520813

Abstract

Objectives

To assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) rate after caesarian delivery (CD).

Study design

Three hundred eighty patients were randomly assigned to closure with polyglactin non coated suture VICRYL, or with polyglactin coated suture VICRYL Plus after caesarian section. The primary outcome was the rate of SSIs within 30 days after surgery and secondary outcomes were the rate of wound healing complications.

Results

SSI rate was 2.5% in Triclosan group compared to 8.1% with non-coated suture. Use of Triclosan coated suture (TCS) was associated with 69% reduction in SSI rate (p = 0.037; ORa:0.294; 95% CI:0.094–0.921). The use of Triclosan coated suture was associated with statistically lower risk of wound oedema (2.5% vs 10%), (p = 0.019; OR:0.595), dehiscence (3.8% vs 10.6%), (p = 0.023; OR:0.316) and hematoma (p = 0.035; OR:0.423).

Conclusion

Our results confirm the effectiveness of Triclosan coated suture in reducing SSI rate and wound healing disturbances.

Trial registration

Registered at ClinicalTrials.gov / ID (NCT05330650).

Introduction

Surgical site infections are a common and serious complication of all surgical interventions [1]. The pooled incidence of SSI is estimated to 11.8 per 100 of surgical procedures in low-and medium-incomes countries (LMICs) [2].

SSIs results in substantial clinical and economic burden. In fact, prolonged hospital stay, increasing rate of readmission and reintervention, reduction in measures quality of life and high morality are associated with SSIs [3].

Risk factors for the development of surgical site infection can be broadly divided in patient-related and intervention-related (surgical) factors. Most identified patient-related risk factors are age, diabetes, obesity, smoking, malnutrition and immunosuppression. Since these factors are either non modifiable or difficult to control, focus has been placed on limiting surgical factors [4].

Microorganism colonization of suture materials during surgery, has been associated with a higher risk of SSI development; since bacteria can create a protective biofilm and resist to both antimicrobial treatment and to the host immune system [5].

To avoid this risk of colonization, sutures with antimicrobial activity such as Triclosan has been developed. In fact this antimicrobial agent is used to coat suture materials with a proven in vitro and in vivo efficiency on both gram-positive and gram-negative germs [6]. Effectiveness of TCS in reducing SSIs was demonstrated in several studies. A recent metanalysis including 11 957 patients across 25 randomized controlled trials (RCTs) showed that TCS was more effective in reducing SSI risk by 27 percent compared to non-coated suture [1]. Data from twelve other metanalysis concluded that TCS reduced SSI risk by 24 to 39% [3].

Despite these broad evidences, literature lacks data evaluating the effectiveness of TCS use in obstetric surgery. This data insufficiency is even more remarkable in countries with high SSIs incidence such as Tunisia.

The objectives of this study were to assess the effectiveness of Triclosan coated suture in reducing SSIs rate after caesarian delivery (CD).

Materials and methods

Ethics statement

The study was approved by the local ethic committee of Ben Arous hospital, Tunisia. Written consent for participation was obtained from each patient (Appendix 1). Enrollment of the first patient started on November 1^st 2020. Because all protocols were originally written in French, this study was registered on ClinicalTrials.gov (NCT05330650) on August 4^th 2022, after participants enrolment started, due to translation and administrative process delay. Yet registration in ClinicalTrials.gov is not mandated by Tunisian law. The full protocol is available on ClinicalTrials.gov site.

Data collection was conducted in compliance with Tunisian laws regarding personal data protection. The authors confirm that all ongoing and related trials for this procedure are registered.

Study design and participant selection

We performed a mono-centric controlled randomized trial with patients, surgeons and outcome’s assessor triple blinded to treatment. The study was conducted over eight months between November 2020 and June 2021 in the obstetrics and gynecology department of Ben Arous hospital, Tunisia. Pregnant women with elective or emergency caesarian delivery were included. Were excluded from this study all women with either suspected or confirmed chorioamnionitis or SARS-COV2 infection. Patients’ enrolment started on November 1^st 2020 and follow-up of the last included patient ended on June 30^th 2021.

Once written informed consent was obtained, patients eligible for the study, were randomized intraoperatively into two groups:

Group 1: Suture with polyglactin non coated suture VICRYL

Group 2: Suture with polyglactin coated suture VICRYL Plus

Randomization and blinding

The randomization sequence was computer generated using Random Allocation Software 1.0.0 (Freeware). The patients were block randomized with equal block sizes of 20 items per block (allocation of patients per block is 1:1).

The suture materials for each group were placed in opaque sealed boxes.

The randomization sequence was afterwards provided, in the operative room, in opaque envelopes to a scrub nurse who was not involved in patient’s follow-up. The nurse opened the envelope discreetly and delivered the suture material to the surgeon without uncovering the package, right before wound closure. Macroscopically, it was impossible to distinguish Vicryl® from Vicryl Plus.

Sample size calculation

The rate of SSI after Caesar section in our center was 9% in 2019. Thus, the assumed expected wound infection rates were 2% after using coated suture versus 9% for the control group. On the basis of a two-sided chi-square test for equality of proportions, the study was expected to have 80% power to detect a relative risk reduction of 5%. A total of 296 patients were estimated to be needed, thus, 148 patients were included in each arm. The G*Power 3.1.9.6 software was used to calculate the sample size.

Surgical procedure

Povidone iodine was used for skin preparation. A perioperative antibiotic prophylaxis was administered to all patients. Perioperative hair removal was proscribed. Pfannenstiel incision was performed in all cases. Uterus and aponeurosis closure was performed with an overlock suture with 1/0 thread. Gloves were changed after aponeurosis closure. Subcutaneous tissue was sutured with 2/0 thread. Skin was closed with intradermic suture with 2/0 thread.

Follow up

Patients were followed 30 days after surgery, and four visits were programmed:

Visit 1: Two days after surgery.

Visit 2: 7 days after surgery.

Visit 3: 15 days after surgery.

Visit 4: 30 days after surgery.

In each visit, wound surveillance was performed by the resident in charge on the ward, and if an SSI was suspected the wound was photographed and the patient was referred to a senior surgeon to confirm the diagnosis.

Diagnosis of SSI

We adopted the Centers for Disease Control’s definition (CDC) to diagnose SSI [7]:

Superficial Incisional SSI Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following:

Purulent drainage, with or without laboratory confirmation, from the superficial incision.
Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
Diagnosis of superficial incisional SSI by the surgeon or attending physician.

Deep Incisional SSI Infection occurs within 30 days after the operation if no implant is left in place or within 1 year if implant is in place and the infection appears to be related to the operation and infection involves deep soft tissues (eg, fascial and muscle layers) of the incision and at least one of the following:

Purulent drainage from the deep incision but not from the organ/space component of the surgical site.
A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (38°C), localized pain, or tenderness, unless site is culture-negative.
An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination.
Diagnosis of a deep incisional SSI by a surgeon or attending physician

Outcomes

Primary outcome. The rate of SSIs within 30 days after surgery.

Secondary outcomes. The rate of wound healing complications.

Statistical analysis

Statistical analysis was performed according to the intention-to-treat principle.

To address risk factors involved in SSI development other than suture type, a bivariate analysis using the chi-squared test for nominal variables, the independent Student’s t-test for continuous variables with normal distributions, and the nonparametric Mann-Whitney U test for continuous variables with skewed distributions was first conducted on all independent variables. Any variable with a statistically significant response, or very close to it (p <0.10), was considered a potential confounding factor. A multivariate logistic regression model (Wald test), which considered the impact of all possible confounding factors identified in the bivariate analysis, was used to measure the adjusted effect of suture type on the development of SSI. Calculation 95%CI for proportions we using an online calculator available on sample-size.net.

To compare wound healing disturbances a univariate analysis using Fisher’s exact test for nominal variables and student’s t test for continuous variables was conducted. A p-value < 0.05 (two-sided) was considered to be significant. Statistical analyses were performed using IBM-SPSS version 24 (IBM Corporation, Armonk, New York, USA).

Results

Three hundred fifty patients were screened for eligibility for the study and 340 patients were enrolled. One hundred seventy women (50%) were allocated in the group 1 and 170 (50%) in the group 2.

Ten women were excluded from group 1 and 12 from group 2 for an incomplete follow up. Ultimately, 160/170 (94%) patients remained in the Triclosan arm and 158/170 (93%) in the control arm (Fig 1).

The two groups were well balanced concerning patient characteristics and risk factors of SSI. The Table 1 summarizes patients characteristics and risk factors of SSI.

Table 1. Patients’ characteristics and risk of SSI.

	Group 1 (non-coated suture) ^a n = 160	Group 2 (Coated suture) ^a n = 158
Age (mean)	31.94 ± 0.447	31.92 ± 0.443
BMI (mean)	24.10 ± 0.225	24.360 ± 0.241
Tabacco (number)	22 (13.8%)	11 (7%)
Diabetes Miletus	9 (5.6%)	7 (4.4%)
Anemia	37 (23.1%)	40 (25.3%)
ASA score: ASA 1 ASA 2	124 (77.5%) 36 (22.5%)	119 (75.3%) 32 (20.2%)
Parity	2 ± 1/3	2 ±1/3
Previous laparotomy	90 (0.56%)	93 (58.8%)
Gestational diabetes	48 (30%)	43 (27.2%)
Premature rupture of membrane > 6 H	57 (35.6%)	43 (27.2%)
Premature delivery	23 (14.3%)	25 (15.8%)
Emergency caesarian delivery	98 (61.2%)	71 (44.9%)
Rasor shaving < 48H	49 (30.6%)	41 (25.9%)
Epilation < 48H	93 (58.1%)	103 (68.1%)
Use of Drain	7 (4.3%)	3 (1.8%)
Operative time	37.41 ± 0.409	38.12 ± 0.340

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^a Mean ± Standard error of mean (SEM) for age, body mass index (BMI), and operative time; Median ± 75th/25th percentiles for parity; percentage for tobacco, diabetes miletus, American Society of Anesthesiologists (ASA) score, previous laparotomy, gestational diabetes, premature rupture of membrane, premature delivery, emergency caesarian delivery, razor shaving, epilation and use of drain.

Surgical site infection

The incidence of SSI in our study population was 5.3% (17/318) (95%CI [0.073–0.189]). The SSI was superficial in 15 cases and deep SSI was noted in two patients (11,7%). The two cases were managed by image guided drainage and antibiotics.

All infections were diagnosed within the first fifteen days after surgery, 35% (6/17) at the second visit and 65% (11/17) at the third visit.

When using triclosan coated suture, SSI rate was 2.5% (4/158) (95%CI [0.0008–0.049]) compared to 8.1% (13/160) (95%CI [0.044–0.134]) with non-coated suture. Non coated suture was found to increase SSI risk by 3.4 times (95%CI: 1.085–10.680). Evaluation of SSI confounding factor in bivariate analysis, found diabetes to be a confounding factor (p = 0.037; OR: 4.086; CI95%: 1.058–15.771). Bivariate analysis of SSI’s risk factors is shown in the Table 2.

Table 2. Bivariate analysis of SSI’s risk factors: Chi-squared test for nominal variables, Student’s t-test for continuous variables with normal distributions, Mann-Whitney U test for continuous variables with skewed distributions.

	SSI n = 17	No SSI n = 301	p value	OR (95% CI)
Age (mean)	32.88 ± 5.231	31.88 ± 5.63	0.473	1.399 (-3.757–1.746)
BMI (mean)	24.782 ± 0.223	25.001 ±0,272	0.766	0.735 (- 1.227–1.665)
Tabacco (number)	2 (11.7%)	31 (10.2%)	0.525	0.532 (0.067–4.095)
Diabetes Miletus	3 (17.64%)	13 (4.3%)	0.041	4.086 (1.058–15.771)
Anemia	2 (11.7%)	75 (24.9%)	0.218	0.402 (0.090–1.798)
ASA score = 2	4 (23.52%)	64 (21.26%)	0.812	1.057 (1.029–1.085)
Previous laparotomy	10 (58.82%)	173 (57.74%)	0.913	1.057 (0.392–2.852)
Gestational diabetes	4 (23.52%)	87 (28.9%)	0.786	0.753 (0.239–2.375)
Premature rupture of membrane > 6 H	7 (41.17%)	93 (30.9%)	0.423	1.566 (0.578–4.240)
Premature delivery	2 (11,7%)	50 (15.28%)	0.693	0.739 (0.164–3.341)
Emergency cesarian delivery	10 (58.8%)	159 (52.8%)	0.804	1.276 (0.473–3.441)
Rasor shaving < 48H	6 (35.3%)	84 (27.9%)	0.511	1.409 (0.505–3.932)
Epilation < 48H	11 (64.7%)	185 (61.4%)	0.789	1.150 (0.414–3.193)
Use of Drain	1 (5.89%)	10 (3.32%)	0.459	1.819 (0.219–15.097)
Operative time	37.74 ± 4.818	37.94 ± 4.561	0.866	1.187 (-2.536–2.135)

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OR:Odds Ratio.

In multivariate regression, only use of non-coated suture was associated with a higher risk of SSI. A statistically significant reduction of 70% in SSI rate was associated with Triclosan coated suture use (ORa:0.294; 95%CI:0.094–0.921). Results of the multivariate regression are shown in Table 3.

Table 3. Multivariate logistic regression analysis.

	p value	ORa (95% CI)
Diabetes	0.101	0.316 (0.80–1.250)
Coated suture use	0.036	0.294 (0.094–0.921)

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ORa: Adjusted Odds Ratio.

Wound healing disturbances

The use of Triclosan coated suture was associated with statistically lower risk of wound oedema (2.5% vs 10%), (p = 0.019; OR:0.595), dehiscence (3.8% vs 10.6%), (p = 0.023; OR:0.316) and hematoma (p = 0.035; OR:0.423).

Wound discharges were similar in the two groups (3.2% vs 5.6%) (p = 0.285). Healing time was also comparable and did not reach statistical significance (7.65 ± 1.724 vs 7.65 ± 1.724); (p = 0.121). The Table 4 represents the results of wound healing disturbances in the two groups of the study.

Table 4. Comparison of wound healing disturbance after coated and non-coated suturing in univariate analysis.

	TCS coated suture n = 158	Non coated suture n = 160	p value	OR (95% CI)
Oedema	17 (3.8%)	6 (10.6%)	0.019	0.332 (0.127–0.886)
Dehiscence	8 (5.1%)	22 (13.8%)	0.008	0.335 (0.144–0.776)
Hematoma	9 (5.7%)	20 (12.5%)	0.035	0.423 (0.186–0.960)
Discharge	5 (3.2%)	9 (5.6%)	0.285	0.548 (0.180–1.674)
Healing time	7.65 ± 1.724	7.93 ± 1.724	0.169	0.212 (-0.125–0.709)

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OR:Odds Ratio.

Discussion

We found an SSI risk of 2.5% in TCS coated suture group and 8.1% for the control group. The SSI rate in the control group was lower than expected. In our study, the use of TCS coated suture was found to reduce SSI rate and wound healing disturbances without increasing healing time compared with non-coated suture after caesarian section. By contrast with our assumption that coated sutures would reduce the occurrence of surgical site infection by 78%, the effective reduction in this study was 70%. It can be regarded as clinically relevant from a surgical point of view.

SSIs account for an estimated rate of 20% of all health associated infections (HAIs) globally and they are responsible of considerable morbidity and increasing health care costs [8]. To reduce this risk, several measures had been proposed. One potential strategy is to use antimicrobial coated suture. Many studies had demonstrated the effectiveness of Triclosan coated suture in reducing SSI risk. In contrast, others have failed to demonstrate protective role of TCS use. These discrepancies may be explained by differences in study population, type of procedure, or the layers where the sutures were applied [3].

In the Tristan review [9], two from the four RCTs included and evaluating Vicryl® Plus suture after abdominal surgery confirmed the superiority of Vicryl® Plus in reducing SSI rate [10–12]. In a metanalysis including 25 RCTs comparing TCS coated suture to non-coated suture, Ahmed et al had concluded to 27% reduction of SSI rate when TCS coated suture was used compared with non-coated suture [1]. After clean contaminated surgery, use of TCS coated suture was associated with 31% reduction of SSI rate [13]. Leaper et al, showed that the effectiveness of TCS coated suture was not affected by the wound type and concluded to a clear benefit of reduction of SSIs after all classes of surgery with the TCS suture [14].

The rate of SSI in our current study was 5.3% showing that this complication remains a common and unsolved issue. A significant difference between TCS coated suture arm and the non-coated suture arm was noted. The use of TCS was associated with a reduction of 70% of SSI rate after adjusting confounding factors (ORa = 0.294 (0.094–0.921); p = 0.036), confirming the efficacy of TCS in reducing the risk of SSI.

Effect of triclosan use in wound healing had been evaluated in several studies. Rasic et al found that TCS suture was associated with less inflammatory reaction, dehiscence and incisional hernia after colorectal surgery [11]. Metavelli et al demonstrated that overall wound complication rate was similar between coated and non-coated suture and they found that TCS coated suture was associated with lower incisional hematoma [5]. After saphenectomy, lower wound pain and wound hyperthermia were associated with TCS suture use [15]. In contrast, other studies failed to demonstrate the superiority of coated suture in reducing wound complications. In a RCT evaluating TCS use after pediatric surgery, dehiscence was similar with coated and non-coated suture [16]. Arselan et al did not found differences in rate of wound dehiscence and demonstrated that the coted suture was associated with a higher risk of wound discharge [17]. In all above studies, wound healing time was not affected by TCS suture use.

In our study, the use of Vicryl® Plus was associated with lower risk of wound oedema, wound hematoma and wound dehiscence. Wound healing time was similar in the two groups. Considering these results, and previous studies, it can be concluded that triclosan coated suture presents an opportunity to improve the postoperative wound healing process.

The present study has notable strengths. To our knowledge this study is the first RCT evaluating TCS coated suture in obstetric surgery. Furthermore, as it was unicentric, potential variables such as surgeon experience, SSI prevention measures, and differences across operating rooms were the same in all time periods.

This study is associated with limitations. The fact that the survey was carried out in a single public institution without extending to other health structures, constitutes one of the limitations of our study. Another weakness is that although the SSI rate in the control group was estimated accurate, detection of absolute reduction of 7% was rather ambitious. In fact, the definition of minimal clinically relevant reduction was extensively debated in our study group at the time of protocol development. Eventually we opted for absolute reduction of 7%, relative reduction of 78%, in the sense that every surgeon will support that 7% absolute risk is clinically meaningful.

Conclusion

Through this prospective randomized controlled trial, we were able to establish the effectiveness of Triclosan-based antibacterial suture in reducing the incidence of postoperative infections after caesarean section. The integration of TCS coated suture in daily surgical practice results in a significant reduction in overall healthcare costs.

Supporting information

S1 Dataset. 10.6084/m9.figshare.21330624.

(DOCX)

Click here for additional data file.^{(12KB, docx)}

S1 File. Consort checklist.

(DOC)

Click here for additional data file.^{(218.5KB, doc)}

S2 File. Informed consent form.

(DOC)

Click here for additional data file.^{(45.5KB, doc)}

S3 File. Study protocol.

(DOCX)

Click here for additional data file.^{(742KB, docx)}

Data Availability

The data underlying the results presented in the study are available from Data Set: 10.6084/m9.figshare.21330624.

Funding Statement

The authors received no specific funding for this work.

References

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PLoS One. doi: 10.1371/journal.pone.0278939.r001

Decision Letter 0

Antonio Simone Laganà

28 Aug 2022

PONE-D-22-20609Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled StudyPLOS ONE

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Additional Editor Comments:

The topic of the manuscript is interesting. Nevertheless, the reviewers raised several concerns: considering this point, I invite authors to perform the required major revisions.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

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Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: No

**********

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

**********

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Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

5. Review Comments to the Author

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Reviewer #1: Dear Authors,

This manuscript tried to assess the effectiveness of Triclosan coated sutures in reducing SSI, the rate of wound healing complications, and the cost impact of triclosan-coated suture use from a hospital perspective. I have reviewed the manuscript and would like to suggest following changes in a section-wise manner.

Overall, there are many grammatical and typographical mistakes.

1. Abstract

Abstract seems well written.

2. Introduction

This section needs to be well written and arranged into relevant paragraphs. The authors should first talk in brief about the SSI, risk factors, basics of the suture in the discussion, and how sutures are related to the development of SSI. Following this, the authors should mention recent studies pertaining to the topic and highlight the literature gap. Then, the authors should state how the current study aims to fill the gap.

3. Methodology

The authors have mentioned inclusion, non-inclusion and exclusion criteria. However, there should be only inclusion and exclusion criteria.

There are grammatical and typographical mistakes. Such as chi2 should be replaced with chi-square, Caesar section with caesarean section, and many more.

Also, format the section in proper paragraphs based on the journal’s guidelines. Please make sure to double-check and address all the mistakes.

4. Results

Please format the tables based on the journal’s guidelines. The statistical values mentioned in brackets are confusing.

5. Discussion

The first paragraph should mention the noteworthy findings of the study. The authors should compare and contrast these findings with other studies in subsequent paragraphs. The discussion is too brief. Also, author should add a paragraph regarding limitations and future implications of this study.

6. Conclusion

The conclusion is well written.

7. References

Please format the references based on the journal’s guidelines.

Reviewer #2: A mono-centric prospective controlled randomized trial in pregnant women with elective or emergency caesarian delivery. Patients, surgeons and outcome’s assessor triple blinded to treatment. Three hundred eighty patients were randomly assigned to closure with polyglactin non coated suture VICRYL, or with polyglactin coated suture VICRYL Plus after caesarian section. The primary outcome was the rate of SSIs within 30 days after surgery. SSI rate was 2.5% in Triclosan group compared to 8.1% with non-coated

suture. Use of Triclosan coated suture was associated with 69% reduction in SSI rate (p = 0.037; OR:0.294; CI95%:0.094 – 0.921). The authors claim a total of 5312 USD (33 USD per procedure) was saved with TCS coated suturing; 590 USD per prevented SSI.

Major comments:

No trial registration given.

It seems to be this trial: https://ichgcp.net/clinical-trials-registry/NCT02847936

However, the sample size in that registered trial is 400 and not 296 patients.

Sample size calculations: expected wound infection rates were 2% with coated suture use versus 9% for the control group. On the basis of a two-sided chi2 test for equality of proportions, 80% power to detect a relative risk reduction of 5%, 296 patients were needed, 148 patients per arm. The sample size is powered to test a null hypothesis of this difference: 9% vs 2% is an ARR of 7% and a RRR of 78%. The actual results showed an ARR of 5.6% (8.1-2.5%) and a RRR of 69%. This means that the null hypothesis may be false as the study is underpowered to correctly test a smaller difference than 7%. In other words, the conclusion of the effectiveness of triclosan coated sutures needs to be toned down considerably, coming from an underpowered study.

What was used as standard skin prep? Specifiy at 'surgical procedure'.

"..a scrub nurse verified the randomization list..." (p. 12) Explain this. How could there be a list that the scrub nurse was allowed to look into. Proper computer randomisation allocates treatment group per patient separately. A pre-randomised list of treatment allocations does not count as proper randomisation.

p.13 who did the wound surveillance and decides whether or not a patient was seen by a senior surgeon for suspicion of wound infection?

Cost estimation section needs to be deleted completely, as well as the related conclusion. This is not a proper nor adequate economic analysis. 'Cesarian cost = Bundle cost + Suture material cost + Hospital stay cost' and 'SSI cost = SSI bundle cost + Drugs cost + Investigation tests cost + Reintervention cost + Hospital stay cost' is not accurate, oversimplified, no details supplied, and only a very rough 'quick & dirty' estimate which must be left out because of imprecision and not following the rules of cost analyses.

Statistical analyses paragraph is too concise, lacks detail.

Table 1 baseline characteristics. Since this is a RCT, no statistics must be performed on baseline characteristics as randomisation should take care of random distribution. Delete p value column and related text in results.

Table 2 risk factor for SSI does not contribute to trial results presentation

p.19 'In multivariate regression, only use of non-coated suture was associated with a higher risk of

SSI.' But none of the multivariate data are shown. Do we simply need to believe the authors without any possibility of peer review of the multivariate data? It's also not made available in supplementary materials.

Reviewer #3: This randomized controlled trial assessed the effectiveness of Triclosan coated suture in reducing SSIs rate after caesarian delivery, and to evaluate the cost impact of antimicrobial suture use. They had interesting finding. And the study is well written.

All information about the procedure was described in detail in Method section.

Only one minor concern.

Abstract: 'CI95%' should be '95%CI'.

Reviewer #4: A randomized controlled study was conducted which aimed to assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) after cesarean delivery. The secondary aim was to compare rates of wound healing complications. A statistically significant reduction in the SSI rate was observed with the Triclosan coated suture compared to the control. Furthermore, Triclosan was associated with statistically lower risks of wound oedema, dehiscence and hematoma compared to the control.

Major revision

Provide a comprehensive “Statistical analysis” section. List and describe all the statistical methods used for the analysis.

Minor revisions:

1- Abstract: Define the abbreviation SSI.

2- Page 4, last line: Write out chi-square.

3- Page 5, Randomization: Provide further details of the randomization process. If block randomization was used, state the block size.

4- Page 8, Statistical analysis: The statements “p degrees of significance” and “the results were presented with their p” are confusing. Please clarify or restate.

5- Page 8, Statistical analysis: Indicate the type of nonparametric tests used and the specific data that was analyzed with these tests.

6- Page 8: Provide corresponding percentages for the counts in these sentences.

A. “One hundred seventy women were allocated in group 1 and 170 in group 2.”

B. “Ultimately, 160 patients remained in the Triclosan arm and 158 in the control arm . . .”

7-Page 8: Define groups 1 and 2 at first mention.

8- Table I: In addition to means, provide standard deviations. In addition to counts, provide percentages. If the data is not normally distributed, provide median, first and third quartiles.

9- Page 11, Second paragraph: Provide 95% confidence intervals for the 2.5% and 8.1%.

10- In the “Statistical analysis” section indicate that both univariate and multivariate analysis were performed. The univariate results are shown in Table II. Clarify.

11- Page 13, lines 1-3: Clarify which factors remained in the multivariate regression model.

12- In the “Statistical analysis” section list and thoroughly describe the use of all statistical methods. Indicate if univariate or multivariate logistic regression was used for the wound healing disturbances (results shown on page 13 and Table III). For further clarity, in the title of Table III, indicate if the results are univariate or multivariate.

13- Page 13: Provide the discharge rates and summarize the healing times in the two groups.

14- Page 14: Provide measures of dispersion for each hospital cost. Indicate if the summary statistics are means, medians, etc.

15- To assist in the review process, add line numbering to the document.

**********

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Reviewer #1: Yes: Ayush Anand

Reviewer #2: Yes: Prof MA Boermeester

Reviewer #3: Yes: Jian-Hong Zhong

Reviewer #4: No

**********

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PLoS One. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939.r002

Author response to Decision Letter 0

13 Oct 2022

Thank you for giving us the opportunity to submit a revised draft of the manuscript “Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled Study”. We appreciate the time and the effort that you and the reviewers dedicated to provide feedback on our manuscript and we are grateful for the insightful comments and valuable improvements to our paper. We have incorporated most of the suggestions made by the reviewers. Those changes are highlighted within the manuscript. Please see below for a point-by-point response to the reviewers’ comments and concerns. All page numbers refer to the revised manuscript file with tracked changes.

Reviewers' Comments to the Authors:

Reviewer 1: This manuscript tried to assess the effectiveness of Triclosan coated sutures in reducing SSI, the rate of wound healing complications, and the cost impact of triclosan-coated suture use from a hospital perspective. I have reviewed the manuscript and would like to suggest following changes in a section-wise manner. Overall, there are many grammatical and typographical mistakes.

Comment from reviewer one concerning the Abstract: Abstract seems well written.

Author response: Thank you.

Comment from reviewer 1 concerning specific change in the introduction: This section needs to be well written and arranged into relevant paragraphs. The authors should first talk in brief about the SSI, risk factors, basics of the suture in the discussion, and how sutures are related to the development of SSI. Following this, the authors should mention recent studies pertaining to the topic and highlight the literature gap. Then, the authors should state how the current study aims to fill the gap.

Author response: We agree with the reviewer’s assessment. Accordingly, we have revised the introduction. We included SSI risk factors in page 2 (line 50 to 54), basics of suture and relation between suture and SSI in page 2 (line 55 to 60). Recent studies were cited in page 2 (line 60 to 65). We tried to explain gap in literature in page 3 (line 66 to 70).

Comment from reviewer 1 concerning the methodology: The authors have mentioned inclusion, non-inclusion and exclusion criteria. However, there should be only inclusion and exclusion criteria. There are grammatical and typographical mistakes. Such as chi2 should be replaced with chi-square, Caesar section with caesarean section, and many more. Also, format the section in proper paragraphs based on the journal’s guidelines. Please make sure to double-check and address all the mistakes.

Author response: Thank you for pointing this out. Section format was modified. We removed the non-inclusion criteria and we tried to correct all grammatical mistakes by a double-check (page 4 to page 8).

Comment from reviewer 1 concerning the section “Results”: Please format the tables based on the journal’s guidelines. The statistical values mentioned in brackets are confusing.

Author response: Thank you for pointing this out. All tables format has been modified based on journal’s guidelines.

Comment from reviewer 1 concerning the section “Discussion”: The first paragraph should mention the noteworthy findings of the study. The authors should compare and contrast these findings with other studies in subsequent paragraphs. The discussion is too brief. Also, author should add a paragraph regarding limitations and future implications of this study.

Author response : We tried to mention our finding in the first paragraph of the discussion in page 13 (line 239 to 243) and finding were compared as recommended in page 14 (line 253 to 260). A paragraph that mention the limitation of the study were added in page 15 (line 286 to 293).

Comment from reviewer 1 concerning the section “Conclusion”: The conclusion is well written.

Author response: thank you.

Comment from reviewer 1 concerning the section “References”: Please format the references based on the journal’s guidelines.

Author response : section references has been modified based on journal’s guidelines.

Reviewer 2: A mono-centric prospective controlled randomized trial in pregnant women with elective or emergency caesarian delivery. Patients, surgeons and outcome’s assessor triple blinded to treatment. Three hundred eighty patients were randomly assigned to closure with polyglactin non coated suture VICRYL, or with polyglactin coated suture VICRYL Plus after caesarian section. The primary outcome was the rate of SSIs within 30 days after surgery. SSI rate was 2.5% in Triclosan group compared to 8.1% with non-coated

Comment from reviewer 2 concerning the trial registration: No trial registration given.

It seems to be this trial: https://ichgcp.net/clinical-trials-registry/NCT02847936

However, the sample size in that registered trial is 400 and not 296 patients.

Author response: Thank you for pointing this out. The trial registration was not mentioned in the manuscript. Our trial registration does not correspond to the trial mentioned by the reviewer.

The trial registration figures in page 1 at the title and the section “Ethics statement” at page 4 (line 72) in the revised manuscript.

Comment from the reviewer 2 concerning “Sample size calculations”: expected wound infection rates were 2% with coated suture use versus 9% for the control group. On the basis of a two-sided chi2 test for equality of proportions, 80% power to detect a relative risk reduction of 5%, 296 patients were needed, 148 patients per arm. The sample size is powered to test a null hypothesis of this difference: 9% vs 2% is an ARR of 7% and a RRR of 78%. The actual results showed an ARR of 5.6% (8.1-2.5%) and a RRR of 69%. This means that the null hypothesis may be false as the study is underpowered to correctly test a smaller difference than 7%. In other words, the conclusion of the effectiveness of triclosan coated sutures needs to be toned down considerably, coming from an underpowered study.”

Author response: We agree that this is a potential limitation of the study and we tried to figure this weakness and to explain it in the section “Discussion” at the page 15 (line 288 to 293).

Comment from the reviewer 2 concerning “Skin preparation: What was used as standard skin prep? Specify at 'surgical procedure'.

Author response: The skin preparation used was added in section “Surgical procedure’ at page 6 (Line 113).

Comment from the reviewer 2 concerning “The randomization procedure”: “a scrub nurse verified the randomization list..." (p. 12) Explain this. How could there be a list that the scrub nurse was allowed to look into. Proper computer randomization allocates treatment group per patient separately. A pre-randomized list of treatment allocations does not count as proper randomization.

Author response: We agree that the section randomization lacks details and was not well described. In the revised manuscript we tried to clarify and to meticulously describe the procedure of randomization in the section “Randomization and blinding” at the page 5 (line 95 to 104).

Comment from the reviewer 2 concerning “the wound surveillance”: who did the wound surveillance and decides whether or not a patient was seen by a senior surgeon for suspicion of wound infection?

Author response: Thank you for pointing this out. Wound surveillance was made by the resident in charge on the ward. Page 6 (line 124).

Comment from the reviewer 2 concerning “Cost estimation”: Cost estimation section needs to be deleted completely, as well as the related conclusion. This is not a proper nor adequate economic analysis. 'Cesarian cost = Bundle cost + Suture material cost + Hospital stay cost' and 'SSI cost = SSI bundle cost + Drugs cost + Investigation tests cost + Reintervention cost + Hospital stay cost' is not accurate, oversimplified, no details supplied, and only a very rough 'quick & dirty' estimate which must be left out because of imprecision and not following the rules of cost analyses.

Author response: We agree with the reviewer that the method to estimate cost was not appropriate and the section and its related conclusion were deleted from the revised manuscript.

Comment from the reviewer 2 concerning the section “Statistical analysis”: Statistical analyses paragraph is too concise, lacks detail.

Author response: We tried to clarify the paragraph by listing and describing all the statistical methods used for the analysis at page 7 and 8 (line 154 to 167).

Comment from the reviewer 2 concerning Table 1: Table 1 baseline characteristics. Since this is a RCT, no statistics must be performed on baseline characteristics as randomization should take care of random distribution. Delete p value column and related text in results.

Author response: We totally agree with the reviewer and p value column and related text was deleted.

Comment from the reviewer 2 concerning Table 2: Table 2 risk factor for SSI does not contribute to trial results presentation.

Author response : While we appreciate the reviewer’s feedback, we respectfully disagree. Since development of SSI is multifactorial, the bivariate analysis was conducted to define confounding factors.

Comment from the reviewer 2 concerning “Multivariate analysis”: p.19 'In multivariate regression, only use of non-coated suture was associated with a higher risk of SSI.' But none of the multivariate data are shown. Do we simply need to believe the authors without any possibility of peer review of the multivariate data? It's also not made available in supplementary materials.

Author response: As suggested results of multivariate analysis were added in the revised manuscript at page 12.

Reviewer 3: This randomized controlled trial assessed the effectiveness of Triclosan coated suture in reducing SSIs rate after caesarian delivery, and to evaluate the cost impact of antimicrobial suture use. They had interesting finding. And the study is well written. All information about the procedure was described in detail in Method section. Only one minor concern 'CI95%' should be '95%CI'.

Author response: Thank you.

Reviewer 3: A randomized controlled study was conducted which aimed to assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) after cesarean delivery. The secondary aim was to compare rates of wound healing complications. A statistically significant reduction in the SSI rate was observed with the Triclosan coated suture compared to the control. Furthermore, Triclosan was associated with statistically lower risks of wound oedema, dehiscence and hematoma compared to the control.

Comment from the reviewer 3 concerning the section “Statistical analysis”:

Provide a comprehensive “Statistical analysis” section. List and describe all the statistical methods used for the analysis.

Page 4, last line: Write out chi-square

The statements “p degrees of significance” and “the results were presented with their p” are confusing. Please clarify or restate.

Indicate the type of nonparametric tests used and the specific data that was analyzed with these tests..

Author response: We tried to clarify the paragraph by Listing and describing all the statistical methods used for the analysis at page 7 and 8 (line 154 to 167).

Comment from the reviewer 3 concerning the section”Abstact”: Define the abbreviation SSI.

Author response : Thank you for pointing this out. The abbreviation has been defined.

Comment from the reviewer 3 concerning the section “Statistical analysis”:

Page 4, last line: Write out chi-square

The statements “p degrees of significance” and “the results were presented with their p” are confusing. Please clarify or restate.

Indicate the type of nonparametric tests used and the specific data that was analyzed with these tests.

Comment from the reviewer 3 concerning “Providing percentage”: Provide corresponding percentages for the counts in these sentences.

A. “One hundred seventy women were allocated in group 1 and 170 in group 2.”

B. “Ultimately, 160 patients remained in the Triclosan arm and 158 in the control arm

Author response: Thank you for pointing this out. Percentage has been added at page 8 (line 169 to 174).

Comment from the reviewer 3 concerning: Define groups 1 and 2 at first mention.

Author response: Thank you for pointing this out. The two groups were defined as recommended at page 5 (Line 93 and 94).

Comment from the reviewer 3 concerning” Table 1”: In addition to means, provide standard deviations. In addition to counts, provide percentages. If the data is not normally distributed, provide median, first and third quartiles.

Author response: Standard deviation, percentage were added in table 1 to normally distributed data and median, first and third quartiles were also mentioned. Page 9

Comment from the reviewer 3 concerning “Adding standard deviation”: Page 11, Second paragraph: Provide 95% confidence intervals for the 2.5% and 8.1%.

Author response: These two percentages define the rate of SSI in the two groups. No standard deviation could be calculated.

Comment from the reviewer 3 concerning “Multivariate analysis”:

In the “Statistical analysis” section indicate that both univariate and multivariate analysis were performed. The univariate results are shown in Table II. Clarify.

Clarify which factors remained in the multivariate regression.

Author response: As suggested results of multivariate analysis were added in the revised manuscript at page 12.

Comment from the reviewer 3 concerning: In the “Statistical analysis” section list and thoroughly describe the use of all statistical methods. Indicate if univariate or multivariate logistic regression was used for the wound healing disturbances (results shown on page 13 and Table III). For further clarity, in the title of Table III, indicate if the results are univariate or multivariate.

Author response: Thank you for pointing this out. In the revised manuscript we had mentioned that univariate analysis was used to compare wound healing disturbances at page 8 line 165.

Comment from the reviewer 3 concerning: Providing the discharge rates and summarizing the healing times in the two groups.

Author response: We described these two parameters at page 12 (line 224 to 226) and in Table 3.

Comment from the reviewer 3 concerning “Hospital cost”: Provide measures of dispersion for each hospital cost. Indicate if the summary statistics are means, medians, etc.

Author response: The section of hospital cost has been deleted as recommended.

Comment from the reviewer 3 concerning “Adding line numbering to the document” : To assist in the review process, add line numbering to the document.

Author response: Thank you it was a very helpful suggestion.

Reviewer 4: A randomized controlled study was conducted which aimed to assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) after cesarean delivery. The secondary aim was to compare rates of wound healing complications. A statistically significant reduction in the SSI rate was observed with the Triclosan coated suture compared to the control. Furthermore, Triclosan was associated with statistically lower risks of wound oedema, dehiscence and hematoma compared to the control.

Major revision

Provide a comprehensive “Statistical analysis” section. List and describe all the statistical methods used for the analysis.

Author response: the statistical analysis section was revised. We tried to clarify the paragraph by listing and describing all the statistical methods used for the analysis at page 7 and 8 (line 154 to 167).

Minor revisions:

1- Abstract: Define the abbreviation SSI.

2- Page 4, last line: Write out chi-square.

3- Page 5, Randomization: Provide further details of the randomization process. If block randomization was used, state the block size.

4- Page 8, Statistical analysis: The statements “p degrees of significance” and “the results were presented with their p” are confusing. Please clarify or restate.

5- Page 8, Statistical analysis: Indicate the type of nonparametric tests used and the specific data that was analyzed with these tests.

6- Page 8: Provide corresponding percentages for the counts in these sentences.

A. “One hundred seventy women were allocated in group 1 and 170 in group 2.”

B. “Ultimately, 160 patients remained in the Triclosan arm and 158 in the control arm . . .”

7-Page 8: Define groups 1 and 2 at first mention.

8- Table I: In addition to means, provide standard deviations. In addition to counts, provide percentages. If the data is not normally distributed, provide median, first and third quartiles.

9- Page 11, Second paragraph: Provide 95% confidence intervals for the 2.5% and 8.1%.

10- In the “Statistical analysis” section indicate that both univariate and multivariate analysis were performed. The univariate results are shown in Table II. Clarify.

11- Page 13, lines 1-3: Clarify which factors remained in the multivariate regression model.

13- Page 13: Provide the discharge rates and summarize the healing times in the two groups.

14- Page 14: Provide measures of dispersion for each hospital cost. Indicate if the summary statistics are means, medians, etc.

15- To assist in the review process, add line numbering to the document.

Thank you for appointing this out. All minor revision were considered and clarified as recommended by reviewer n°4.

Attachment

Submitted filename: RESPONSE to REVIEWERS.docx

Click here for additional data file.^{(25.1KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0278939.r003

Decision Letter 1

Antonio Simone Laganà

26 Oct 2022

PONE-D-22-20609R1Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled StudyPLOS ONE

Dear Dr. BETTAIEB,

Please submit your revised manuscript by Dec 10 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Antonio Simone Laganà, M.D., Ph.D.

Academic Editor

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Reviewer #4: (No Response)

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Reviewer #1: Partly

Reviewer #3: Yes

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Reviewer #3: Yes

Reviewer #4: Yes

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Reviewer #4: Yes

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6. Review Comments to the Author

Reviewer #1: Dear Author, I have reviewed the manuscript and unfortunately, I will not be able to recommend it for publication. This manuscript needs to be extensively edited for english language. Discussion section is not written well.

Reviewer #3: All my comments have been addressed. I think the paper is suitable for publication in PLOS ONE. Thanks again.

Reviewer #4: Minor Revisions:

1- Lines 159 & 165: State the statistical method(s) used for the bivariate and univariate analyses.

2- Table I: To improve clarity, place "n=160" in the Group 1 header and "n=158" in the Group 2 header. Remove these numbers from the cell entries.

3- Lines 190 and 195: Provide 95% confidence intervals for the proportions: 5.3%, 2.5%, and 8.1%. In the Statistical Analysis section, include the statistical method used to estimate the CIs.

4- Table II:

a- In the title state the statistical method used for the bivariate analysis.

b- Provide a measure of dispersion for all means.

c- In similar fashion to comment #2 above, include the sample sizes in the header row and remove them from the individual cells.

5- Table IV: In similar fashion to comment #2 above, include the sample sizes in the header row and remove them from the individual cells.

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Reviewer #1: Yes: Ayush Anand

Reviewer #3: Yes: Jian-Hong Zhong

Reviewer #4: No

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PLoS One. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939.r004

Author response to Decision Letter 1

28 Oct 2022

Thank you for giving us the opportunity to submit a revised draft of the manuscript “Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled Study”. We appreciate the time and effort that you and the reviewers dedicated to provide feedback on our manuscript and we are grateful for the insightful comments on and valuable improvements to our paper. We have incorporated most of the suggestions made by the reviewers. Those changes are highlighted within the manuscript. Please see below, in blue, for a point-by-point response to the reviewers’ comments and concerns. All page numbers refer to the revised manuscript file with tracked changes.

Reviewers' Comments to the Authors:

Reviewer 1 : Dear Author, I have reviewed the manuscript and unfortunately, I will not be able to recommend it for publication. This manuscript needs to be extensively edited for english language. Discussion section is not written well.

Author response : We tried to write the manuscript in a clear language and to correct grammatical and typographical errors.

Reviewer 3 : All my comments have been addressed. I think the paper is suitable for publication in PLOS ONE. Thanks again

Author response : Thank you.

Reviewer 4:

Comment from reviewer 4 concerning bivariate analysis “Lines 159 & 165: State the statistical method(s) used for the bivariate and univariate analyses. “

Author response: Thank you for pointing this out. We tried to describe all statistical methods used for the bivariate analysis in the page 7 and 8 (line 156 to line 159).

Comment from reviewer 4 concerning Table I, Table II and Table IV:

To improve clarity, place "n=160" in the Group 1 header and "n=158" in the Group 2 header. Remove these numbers from the cell entries.

Table II:

a- In the title state the statistical method used for the bivariate analysis.

b- Provide a measure of dispersion for all means.

c- In similar fashion to comment #2 above, include the sample sizes in the header row and remove them from the individual cells.

Table IV: In similar fashion to comment #2 above, include the sample sizes in the header row and remove them from the individual cells.

Author response: We modified Tables as recommended.

Comment from reviewer 4 concerning Providing 95% confidence intervals for the proportions “Lines 190 and 195: Provide 95% confidence intervals for the proportions: 5.3%, 2.5%, and 8.1%. In the Statistical Analysis section, include the statistical method used to estimate the Cis.

Author response: Thank you for the reminder. 95%Cis were provided as recommended and method used was included in page 8 (line 165 to line 166).

Attachment

Submitted filename: RESPONSE 2[14639].docx

Click here for additional data file.^{(14.7KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0278939.r005

Decision Letter 2

Antonio Simone Laganà

25 Nov 2022

Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled Study

PONE-D-22-20609R2

Dear Dr. BETTAIEB,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Antonio Simone Laganà, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

I carefully evaluated the revised version of this manuscript.

Authors have performed the required changes, improving significantly the quality of the paper.

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0278939.r006

Acceptance letter

Antonio Simone Laganà

2 Dec 2022

PONE-D-22-20609R2

Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Prospective Randomized Controlled Study (NCT05330650).

Dear Dr. BETTAIEB:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Antonio Simone Laganà

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 Dataset. 10.6084/m9.figshare.21330624.

(DOCX)

Click here for additional data file.^{(12KB, docx)}

S1 File. Consort checklist.

(DOC)

Click here for additional data file.^{(218.5KB, doc)}

S2 File. Informed consent form.

(DOC)

Click here for additional data file.^{(45.5KB, doc)}

S3 File. Study protocol.

(DOCX)

Click here for additional data file.^{(742KB, docx)}

Attachment

Submitted filename: RESPONSE to REVIEWERS.docx

Click here for additional data file.^{(25.1KB, docx)}

Attachment

Submitted filename: RESPONSE 2[14639].docx

Click here for additional data file.^{(14.7KB, docx)}

Data Availability Statement

The data underlying the results presented in the study are available from Data Set: 10.6084/m9.figshare.21330624.

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PERMALINK

Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650)

Wael Mbarki

Hajer Bettaieb

Nesrine Souayeh

Idriss Laabidi

Hadhemi Rouis

Soumaya Halouani

Rami Boufarghine

Maha Bouyahia

Rahma Bouhmida

Mariem Ouederni

Anissa Ben Amor

Amal Chermiti

Hadir Laamiri

Amira Lika

Imen Chaibi

Hedhili Oueslati

Najeh Hsayaoui

Chaouki Mbarki

Roles

Abstract

Objectives

Study design

Results

Conclusion

Trial registration

Introduction

Materials and methods

Ethics statement

Study design and participant selection

Randomization and blinding

Sample size calculation

Surgical procedure

Follow up

Diagnosis of SSI

Outcomes

Statistical analysis

Results

Fig 1. CONSORT 2010 flow diagram.

Table 1. Patients’ characteristics and risk of SSI.

Surgical site infection

Table 2. Bivariate analysis of SSI’s risk factors: Chi-squared test for nominal variables, Student’s t-test for continuous variables with normal distributions, Mann-Whitney U test for continuous variables with skewed distributions.

Table 3. Multivariate logistic regression analysis.

Wound healing disturbances

Table 4. Comparison of wound healing disturbance after coated and non-coated suturing in univariate analysis.

Discussion

Conclusion

Supporting information

Data Availability

Funding Statement

References

Decision Letter 0

Antonio Simone Laganà

Roles

Author response to Decision Letter 0

Decision Letter 1

Antonio Simone Laganà

Roles

Author response to Decision Letter 1

Decision Letter 2

Antonio Simone Laganà

Roles

Acceptance letter

Antonio Simone Laganà

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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