Role of single-ring oval disposable wound protecting device in preventing surgical site infection in laparoscopic colorectal resections

Abstract

Context:

Surgical site infections (SSI) continue to be a major cause of morbidity, mortality, prolonged hospital stays and a major reason of financial burden to health-care providers and patients after major abdominal surgeries. Along with infection control practices and care bundles, additional use of devices which protect the wound from contamination is believed to decrease the burden of SSI.

Aims:

This study aims to assess the benefit of single-ring disposable wound protector in preventing SSI, overall complications, hospitals stay and morbidity data in laparoscopic colorectal resection.

Settings and Design:

The study design involves case–control study, retrospective.

Subjects and Methods:

A case–control study comparing single ring oval wound protector versus conventional wound protectors retrospectively between August 2019 and December 2021. The ease of use of the device, rate of SSI, overall complications, hospitals stay and morbidity data were analysed.

Statistical Analysis Used:

The statistical analysis was performed by IBM SPSS Statistics 20 version. All Categorical Variables will be described as frequency and percentage. Continuous variables will be described as mean ± standard deviation. Continuous variables were analysed using t-test and categorical parameters using Fisher’s exact test.

Results:

Of the 110 patients studied, wound Protecting devices were used in 58 patients Wound Protector Group (WPG group) and 62 patients did not use such devices (no WPG). The groups were comparable in demographic features, risk features, systemic illness, type of surgeries undertaken and the specimen extraction wound used. There was a significant decrease in the incidence of SSI (1.7% vs. 16% P ≤ 0.008) and the hospital stay (P ≤ 0.03) when WPG was used compared to the group in which it was not used.

Conclusions:

Apart from the use of infection control practices and care bundles, the use of oval-shaped single-ring wound protector is likely to reduce SSI.

INTRODUCTION

Surgical site infections (SSI) are one amongst the most common hospital-acquired infections in abdominal surgery with reported incidence varying between 15% and 30% despite adequate precautions[1,2,3] and may reach over 40% in colon and rectal surgeries.[4] The Centre for Disease Control and Prevention (CDC) definitions[5] of clean, clean-contaminated, contaminated and dirty operations strategies for reducing SSI has gained worldwide acceptance, however, the burden of SSI still continue to be a major clinical problem.[6,7,8] SSIs have been associated to increase the hospital stay, overall complications and even mortality.[9,10,11] The burden of SSI increases the hospital costs, results in loss of work hours, patient dissatisfaction and litigation costs to the health-care provider.[11,12]

Over the last decade, various measures have been widely adopted to reduce the burden of SSI after the CDC guideline in 2017[13] including pre-operative antiseptic shower, antimicrobial prophylaxis, glycaemic control, maintaining normothermia and oxygenation. As SSI from abdominal surgeries is often due to the contamination of the wound from organisms from the skin and gastrointestinal (GI) tract[5,14] various measures are adopted to prevent it from contamination. Commonly employed methods are to use plastic sterile adhesive drapes or circular-shaped single- or double-ringed devices wherein a plastic drape is attached to a semi-rigid ring so that when the ring is deployed beneath the wound the sterile plastic sheet covers the full thickness of the wound.[15,16,17] However, the efficacy of such devices is not uniformly demonstrated in multicentre trials and literature analysis.[17,18,19] This study is a case–control study on the efficacy of an improved design single-ringed wound protecting device in preventing SSI and overall results in elective colorectal cancer surgery.

SUBJECTS AND METHODS

This study was performed in the department of GI surgery between August 2019 and December 2021 in Aster Medcity, Kochi, Kerala, India. During this study, disposable wound protecting device was used routinely in 58 patients during extraction of the specimen after transection. During this period, 62 patients underwent a similar procedure without the use of wound protecting device. Surgeons used a cut piece of plastic sleeve (which is also used as camera cover) measuring about 10 cm in length for wound protection while extraction of the specimen. The study design was a retrospective case–control study.

The device: The device used in this study is a single-ringed disposable wound protector-PRAN Wound Protector (PRAN Medsystems®, Kerala, India Inc.). The device consists of an oval pliable ring measuring 8 cm × 5 cm to which 75 μ thick plastic sheet is fused [Figure 1]. The plastic sheet spreads out for 30 cm all around the oval ring. Owing to the pliable nature of the ring, a surgeon can mould the ring to the elongated shape for easy insertion. Once inserted, the ring attains its original dimension, oval shape and remains open with 8 cm × 5 cm.

Figure 1.

Single ring wound protector device which is an oval pliable ring measuring 8 cm × 5 cm to which 75 μ thick 30 cm spread of plastic sheet all sides

A 5–7 cm incision was made (depending on the bulk of the specimen) either in the sub-umbilical region in the midline or as a small Pfannenstiel incision of the same size. Once the peritoneum is opened, a retractor is used to lift and retract one end of the wound and the surgeon introduces the pliable oval-shaped ring of the wound protector beneath the wound and deploys the entire ring beneath the wound using a gentle push. Further, the attached plastic sheet is brought and spread all around the wound and the surrounding surgical field. The edges of the transparent sheet can be pulled and fixed to the surgical towels for stabilisation and to get a retraction of the wound. The specimen is then delivered through the middle of the protected wound [Figure 2]. Once the specimen delivery is complete, the disposable wound protector can be removed by pulling the attached plastic sheet from one end of the wound, which flips off the wound easily [Figure 3]. In the control group, patients a piece of camera cover were used for the wound protection.

Figure 2.

A colectomy specimen delivered through the deployed single ring wound protector device

Figure 3.

Removal of the disease by pulling one end of the plastic sheet without touching the wound edges

The patient demographic data, comorbid conditions, length of the specimen extraction wound, time taken for the deployment of the wound protecting device, surgeons’ opinion about the usefulness of the device (on a scale of 0–3, with 0 being not useful, 1 somewhat useful, 2 useful and 3 being extremely useful), the rate of SSI, overall complications and hospital stay were prospectively collected.

The statistical analysis was performed by IBM SPSS Statistics for Windows, Version 20.0. (Armonk, NY: IBM Corp.). All categorical variables will be described as frequency and percentage. Continuous variables will be described as mean ± standard deviation. Continuous variables were analysed using t-test and categorical parameters using Fisher’s exact test.

RESULTS

There were 58 patients in the Wound Protector Group (WPG) and 62 in no WPG (no WPG) with mean age group of 62 and 65 years, respectively. Both groups are comparable in terms of age, body mass index, obese persons and risk of anaesthesia with respect to the American Society of Anaesthesiologists classification [Table 1]. Similarly, there was no statistical difference in patients with diabetes mellitus, smokers, renal failure, or other systemic illnesses. There were 22 (38%) patients and 27 (44%) patients with rectal cancers in WPG and no WPG groups, respectively, and the number of patients who underwent pre-operative chemoradiation was comparable between these groups. Colonic resections involved sigmoid colectomies, left hemicolectomies and right hemicolectomies and their numbers were also not statistically different.

Table 1.

Patient demographics, details of the procedures and complications

Variable	WPD (n=58), n (%)	No WPD (n=62), n (%)	P
Age (mean±SD)	61.9 (2.4)	64.8 (3.6)	<0.51
BMI	25.26 (4.8)	25.55 (5.2)	<0.96
BMI >30	3	3	NS
ASA	2.28 (1.1)	2.20 (1.4)	<0.96
Diabetes mellitus	20 (34)	23 (37)	<0.84
Smoking	10 (17.2)	16 (25.8)	<0.28
Renal failure	7 (12)	8 (12.9)	NS
Pre-operative radiation	19 (32.7)	23 (37)	<0.7
Colonic resections	36 (62)	35 (56)	NS
Rectal resections	22 (38)	27 (44)	NS
Stoma	19 (32.7)	24 (38.7)	<0.56
Subumbilical incison	42 (72)	45 (73)	NS
Pfannensteil incsion	16 (18)	17 (17)	NS
Deployment time (s)	16 (2.1)	24 (3.6)	<0.06
Surgeons assessment score	2.8 (0.8)	1.2 (0.8)	<0.16
SSI	1 (1.7)	10 (16)	<0.008
Anastomotic leak	2 (3.4)	4 (6.4)	<0.68
Hospital stay	5.8 (0.8)	8.8 (1.1)	<0.03
30 days morbidity	1 (1.7)	6 (9.6)	<0.11

WPD: Wound protector device, BMI: Body mass index, ASA: American Society of Anesthesiologists, SSI: Surgical site infections, SD: Standard deviation, NS: Not significance

Majority of the specimen extractions were done through sub-umbilical incision, 42 versus 45 patients in WPG and no WPG groups, respectively, and the remaining 16 and 17 patients in these groups respectively had Pfannenstiel incision for specimen extraction (P = ns). The mean specimen extraction wound sizes were 5.8 versus 6.1 cm respectively and were comparable between the arms. The time required for the deployment of the WPG was 16 s versus 24 s (P ≤ 0.06), though not statistically significant, deployment time of WPG was shorter. Similarly, the surgeon’s individual assessment score was also not significantly different, but the score was higher (2.8 vs. 1.2) in the WPG group. The soft-tissue infection rate was significantly lower (1.7% vs. 16%, P ≤ 0.008) in the WPG group. The anastomotic leak, 30-day morbidity was comparable between WPG and no WPG groups. However, the hospital stay was significantly shorter (5.8 days vs. 8.8 days, P ≤ 0.03) in the WPG group.

DISCUSSION

The burden of SSIs after abdominal surgeries still continues to be a major clinical challenge despite the adoption of various care bundles and recommendations.[8,9,13] SSI continues to be an issue resulting in increased morbidity, hospital stay and financial burden to the patients in colorectal surgeries.[3,8] It has been demonstrated that the burden of SSIs after GI surgery varies from 9.4% to 14% to 23.2% in high-income, middle-income and low-income groups according to the UN’s human development index data respectively in a recent large international study including 12539 patients from 66 countries.[20] Hence, continued efforts are made worldwide to implement various additional measures like care bundles which have demonstrated about 40% reduction in the rate of SSI.[21] In colorectal surgeries, the source of infection based on culture data appears to be contamination from the skin or from the gut contents from the operation field itself; hence, the use of adhesive drapes or wound protecting devices have been used very widely to prevent this contamination.[14,15,16] However, the usefulness of these measures or devices have not been consistently proven in the published multicentre trials of meta-analyses.[17,18,19]

The current study has utilised an improved design single-ringed oval-shaped PRAN wound protector and has demonstrated a significant decrease in the incidence of SSI (1.7% vs. 16% P ≤ 0.008) and the hospital stay (P ≤ 0.03) when WPG was used compared to the group in which it was not used. Our results of 16% SSI are comparable to the current incidence even on those without WPG as we comply with current recommendations to prevent SSI; and in addition, we employ care bundles like sterile closure sets, oral antibiotics along with bowel preparation and pre-closure change of gloves.[8,21,22] ROSSINI trial,[17] a multicentre trial conducted in the UK has not demonstrated any benefit of using wound protecting devices in decreasing SSI with 24.7% in device groups versus 25.4% on those without device. Authors themselves have commented that though the study was a well-designed randomised blinded trial their overall infection rates were high even in clean and clean-contaminated surgeries and even though wound protecting devices were used other infection control practices such as routine change of gloves, drapes and instruments before closure of the wound.

Currently, available wound protecting devices are sterile adhesive sheets, single- or double-ringed wound protectors with attached plastic sheets to the ring.[15,16,17] The sterile adhesive sheets have not been demonstrated to improve the SSI in review of multiple trials.[20] However, the wound-protecting devices appears to be helpful in decreasing the incidence of SSI[16,18,19,23] except for data from a multicentre trial.[17] Most of these studies used the Alexis® O-ring device (Applied Medical California, USA) or similar designs. These devices are 2 pliable circular rings connected to each other with a plastic sleeve in a cylindrical manner. After deploying one ring under the wound surgeon has to roll-in the outside ring to the thickness of the wound for effective utilisation of the device. We feel that the single-ringed oval wet packing density used in this current study (PRAN® wound protector) is an improved design and easy-to-deploy device compared to the double-ringed retractor in three aspects. (a) most specimen extraction wounds attain an oval shape after the completion of incision and once a circular device is deployed, we have observed that either end of the wound remain uncovered fully. The device in the current study completely covers the wound particularly its edges because of its oval shape pliable ring and attached 30 cm sheet. (b) Once the double-ringed device is deployed it covers the part of the wound and the area covered by the top ring making possible to allow the spillage from the delivered specimen back to the wound as it covers only a limited circumference. The plastic sheet attached to the device used in this study can be stretched and fixed on all 4 corners using towel clips for stabilisation and to get a retraction of the wound. This device has a sheet which spreads outside the wound for 30 cm all around thereby covering the entire thickness of the wound and its surroundings so that there is very little risk of tissue fluid trickling back to the wound from the specimen. (c) It is very easy to deploy the device in this study with a deployment time of about 16 sec and to remove the device; surgeon can flip off the device from one end pulling the plastic sheet ensuring no touch to the protected wound. The O-ringed double shape has to be unwound and pulled out of the wound, usually by putting a finger beneath the wound thereby increasing the risk of contamination. The level of satisfaction of the surgeon with the use was better with the current device, though it did not reach statistical significance. The camera sleeve used in the control group does not effectively protect the wound as it often slips out or gets dislodged along with the delivery of a bulky specimen. The current position paper by the World Society of Emergency Surgery Guidelines on the management of intra-abdominal infections also has concluded that these wound-protecting devices are helpful in preventing SSI barring the issue of their availability and their cost.[23] The current study has its own limitations due to its relatively small number and the retrospective nature of this study. We have not performed a detailed cost analysis of this device in comparison with double-ringed wound protector owing to the retrospective nature of the study; however, the cost of the consumable used is about 50% less with single ring wound protector used in this study in comparison with double-ring wound protecting device. Further trials with a greater number of patients in a randomised manner are warranted to substantiate these results.

CONCLUSIONS

It is very important for the surgeons to adopt best infection control practices, adopt specific care bundles specific to GI or colorectal surgeries to decrease the burden of SSI. Wound-protecting devices are an additional measure which has been demonstrated to reduce the SSIs further. This study demonstrates that the use of improved design single ring oval-shaped wound protector is easy to use and it reduces SSI and hospital stay significantly.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.