Comparison of the wound healing and complications of zipper type closure adhesive tape and stapler for surgical wound suture: A randomized control, single‐centre, open‐label trial

Abstract

Xkin closure is a newly developed medical suture device for lacerations and surgical wounds that can reduce scarring, pain and the risk of infection compared with conventional sutures or staplers. A randomized controlled study was performed to compare the wound healing effects and complications of Xkin closure with stapler closure. Fifty patients who underwent robot‐assisted radical prostatectomy for prostate cancer were randomly assigned. Only the wound above the navel, which was extended to take out the prostate was targeted. The wound was examined at 2, 6 and 12 weeks after surgery, and the modified Vancouver Scar Scale (mVSS), scar height and side effects were assessed with a 3D skin analyser. Forty‐six patients (23 Xkin, 23 Stapler) were analysed. The mVSS scores, vascularity and pliability were significantly lower in the Xkin group compared with the stapler group at the 12‐week follow‐up. No significant differences in the maximum peak and depth of the scars were detected between the two groups using 3D photographs at 12 weeks. Xkin is an effective wound closure method for improving scar outcomes. This method is expected to be widely used for surgical wounds and lacerations caused by trauma in daily life.

1. INTRODUCTION

Postoperative scars often cause cosmetic and functional issues that compromise patients' quality of life. ¹ Hypertrophic scars can cause itching, pain and hyperesthesia. ² Secure wound closure is crucial to minimize wound complications. ³ Surgical wounds require sustained mechanical support to keep the wound edges approximated and allow the wounds to heal without tension. ⁴ Traditionally, surgical sutures and metallic staples were widely used to close wounds. ⁵ These methods are safe and effective but are time‐consuming and require extra staff and costs for suture/staple removal. ⁶ In addition, sutures and staples may cause pain and fear when staples are removed. ⁷ , ⁸ Zip‐type wound closures, which were first reported in the early 2000s, are an atraumatic and non‐invasive alternative to sutures and staples. ⁴ Zip‐type wound closures utilize adhesive strips on either side of the wound, with zip ties traversing the wound that are linked in a zigzag pattern between adjacent rows. ⁹

Prostate cancer (PCa) is currently the most diagnosed cancer (excluding nonmelanoma skin cancer) and the second leading cause of cancer death among men in the United States. ¹⁰ Localized PCa is frequently treated with robot‐assisted radical prostatectomy (RARP). ¹¹ Since the US Food and Drug Administration approval for da Vinci‐assisted prostate surgery in 2001, robotic prostatectomy has become the most commonly performed robotic oncologic procedure in the United States. ¹² Wound exposure is less frequent in abdominal surgery compared with thyroid or knee surgeries. Therefore, the cosmetic results of postoperative wounds in abdominal surgery are reported less frequently. However, the number of patients treated for PCa is increasing along with the incidence of PCa. Patients with PCa are treated using similar tools and the surgical wounds are of similar size. Thus, evaluating surgical wounds after RARP is meaningful. The results of studies comparing zip‐type skin closure devices with staples are relatively consistent, but most of the studies did not objectively analyse the wound, and only a few studies were in the areas of urology. ¹³ , ¹⁴

Xkin (Surginus Co., Ltd, Korea) (Figure S1) is a newly developed zip‐type skin closure device. The tensile strength and adhesive strength of Xkin are similar to existing zip‐type skin closure devices, but the height of the structure is less than 3 mm, reducing discomfort caused by pressure when the device is pressed depending on the body position. In addition, pain caused by pulling is minimized by fixing the left and right sides of the affected area with the same strength when attached, and the wound area is easy to dress because the affected area is sufficiently open. The objective of this study was to compare the efficacy in wound healing and related complications of Xkin with conventional skin staplers.

2. MATERIALS AND METHODS

2.1. Ethics statement

This study was approved by the Institutional Review Board of Seoul National University Bundang Hospital (IRB No. B‐2208‐776‐001). Informed consent was obtained from all patients enrolled in the study. Personal identifiers were removed, and the data were anonymously analysed. All methods were performed according to the relevant guidelines and regulations.

2.2. Study design and population

A randomized controlled, single‐center, open‐label clinical trial was conducted (cris.nih.go.kr No. KCT0008685). The study conformed to the CONSORT 2010 guidelines. ¹⁵ Patient recruitment was conducted from November 2022 to February 2023 in single tertiary large volume centre. The inclusion criteria were as follows: (1) adult patients who planned to undergo RARP for PCa; (2) prostate size less than 60 cc based on multiparametric‐magnetic resonance imaging before surgery to control the wound length; and (3) written informed consent for surgery and trial inclusion. The exclusion criteria were as follows: (1) uncontrolled medical diseases; (2) uncontrolled infections; and (3) taking medications that affect inflammation and wound healing, such as isotretinoin, anticancer drugs, high‐dose corticosteroids and anticoagulants. A multiport approach was used in both groups, and the Davinci X or the Davinci Xi with the same size and type of robot arm ports and assist ports was used in all surgeries. All surgeries were performed by a single surgeon (SL). Only the wound above the navel, which was extended to take out the prostate after RARP, was assessed.

2.3. Randomization and blinding

The 50 patients were randomized in a 1:1 ratio using SAS version 9.4 permuted block randomization without stratification. Randomization was performed by an independent researcher (GJ), not the surgeon, immediately before surgery. Each random assignment was sealed individually in a non‐transparent envelope. Group assignment was performed consecutively with subjects receiving Xkin closure (treatment group) or stapler (control group). The surgeon (S.L.) was not blinded at the time of skin closure and was not involved in the evaluation.

2.4. Intervention using Xkin or staples

In both groups, the prostate specimen was removed through an incision 3 cm above the navel. The peritoneum‐fascia‐subcutaneous layer was closed in the same manner using the same suture in all patients. The skin incision was closed using Xkin or a stapler depending on the randomization. Dressing was applied in the same manner in both groups.

2.5. Study outcomes

Study visits were conducted at 2, 6 and 12 weeks after the surgery. Digital photographs were obtained using identical digital camera settings and lighting conditions on every visit. The wound dehiscence, wound infection and focal side effects such as itching or pain were measured at every visit. All primary and secondary outcomes were evaluated at 12 weeks after the surgery.

The primary outcome was the total and subscale scores of the modified Vancouver Scar Scale (mVSS) at the 12‐week follow‐up. An independent experienced surgeon (S.H.S) graded the clinical outcomes of scars based on mVSS. The VSS was developed to identify pathology and is used to assess the pigmentation, vascularity, pliability and height of hypertrophic scars. ¹⁶ The mVSS is also used to provide expert opinions on scars. ¹⁷ , ¹⁸ The mVSS includes vascularity and pigmentation from 0 to 3, height from 0 to 4 and pliability from 0 to 5. The score for each parameter was assessed separately, and all four scores were added and recorded (0 represents normal skin, while 15 indicates the worst possible outcome).

Secondary outcomes included scar height and side effects. To evaluate the maximum height and depth of the scars, 3D images of the scars were acquired using the Antera 3D® camera (Miravex Limited, Dublin, Ireland) at the 12‐week follow‐up visit and analysed using dedicated software (Antera 3D® camera; Miravex Limited, Dublin, Ireland). The Antera 3D camera is a new three‐dimensional camera developed by Miravex to evaluate skin objective indicators, measuring the texture and colour of the skin by reconstructing three‐dimensional images. ¹⁹ Wound dehiscence and other complications related to the target wound were classified according to the Clavien‐Dindo classification. ²⁰ This grading system is based on five different levels of complications stratified according to the invasiveness of intervention and clinical impact of the complication. ²¹ Grade 3 is a complications needs intervention, considered criterion of severe complication. Details of Clavien‐Dindo classification are attached in the Data S1.

2.6. Sample size and statistical analysis

The sample size was calculated based on a previously conducted study ¹ in which the mVSS mean and standard deviation were 1.619 and 1.244 in the experimental group and 2.500 and 1.540 in the control group, respectively. Based on these results, the sample size was calculated to detect a true mean mVSS score difference of 1 assuming an estimated mean mVSS of 1.6 and 2.6 for the test and control groups and standard deviation of 1.24 at a power of 0.8 and a 0.05 level of significance. ²² At a 1:1 randomization, 25 patients were assigned to each group for the final analysis.

Chi‐squared tests were used to compare categorical variables, and one‐way ANOVA and t‐tests were used to compare continuous variables. A two‐sided p value <0.05 was considered statistically significant. All statistical analyses were performed using IBM‐SPSS® version 29.0 (IBM, Chicago, IL, United States).

3. RESULTS

Fifty patients who underwent RARP for PCa were randomly assigned to the Xkin group or the stapler group. After excluding dropouts (n = 2) and patients whose 3D measurement results were insufficient for analysis (n = 2), 46 patients (23 Xkin, 23 Stapler) were analysed (Figure 1). The average age of the Stapler group was 68.4 ± 6.2 years old, which was older than the Xkin group (63.7 ± 7.1 years old). No significant differences in body mass index, diabetes, or hypertension were detected between the groups. No significant differences in surgery‐related variables, including prostate volume, console time, estimated blood loss, or time for skin closure, were detected between the two groups (Table 1).

FIGURE 1.

Flow chart of the study.

TABLE 1.

Basic characteristics of patients.

	Xkin (n = 23)	Stapler (n = 23)	Normality test
Age (years)	63.7 ± 7.1	68.4 ± 6.2	0.358
BMI (kg/m2)	25.6 ± 2.0	25.1 ± 2.5	0.448
DM, n (%)	1 (4.3)	3 (13.0)
HTN, n (%)	13 (56.5)	10 (43.5)
Prostate Volume (cc)	32.2 ± 10.2	33.5 ± 11.7	0.453
Console Time (min)	58 (55–65)	60 (56–66)	<0.001*
EBL (cc)	50 (40–100)	50 (25–60)	<0.001*
Time for skin closure (s)	250 (179–278)	203 (165–266)	0.011*

^* p < 0.05.

VSS scores (2.17 ± 1.44 vs. 3.48 ± 1.20, respectively; p = 0.002) and vascularity (0.45 ± 0.51 vs. 0.78 ± 0.42, p = 0.027) and pliability (0.60 ± 0.50 vs. 1.00 ± 0.52, p = 0.014) sub‐scores were significantly lower in the Xkin group compared with the scores in the stapler group at the 12‐week follow‐up (Table 2). Representative examples of the surgical wounds in the Xkin and Stapler groups are shown in Figure 2. No significant differences in maximum scar peak (0.20 ± 0.05 vs. 0.18 ± 0.07, p = 0.337) or scar depth (0.21 ± 0.06 vs. 0.21 ± 0.08, p = 0.865) were detected between the two groups at 12 weeks (Figure 3). No wound dehiscence or complications higher than Clavien‐Dindo classification grade 3 occurred in either group.

TABLE 2.

Vancouver Scar Scale at the 2‐, 6‐ and 12‐week follow‐ups.

Variable	2 weeks	6 weeks	12 weeks	p a
mVSS total
Xkin	4.61 ± 1.03	3.39 ± 1.08	2.17 ± 1.44	0.002*
Stapler	8.39 ± 1.62	5.00 ± 1.28	3.48 ± 1.20
Vascularity
Xkin	1.09 ± 0.42	0.83 ± 0.49	0.45 ± 0.51	0.027*
Stapler	1.09 ± 0.42	1.09 ± 0.29	0.78 ± 0.42
Pigmentation
Xkin	1.09 ± 0.29	0.96 ± 0.21	0.85 ± 0.37	0.260
Stapler	2.22 ± 0.60	1.26 ± 0.45	0.96 ± 0.21
Height
Xkin	1.13 ± 0.46	0.74 ± 0.45	0.60 ± 0.50	0.428
Stapler	1.65 ± 0.57	1.00 ± 0.52	0.74 ± 0.62
Pliability
Xkin	1.30 ± 0.56	0.87 ± 0.55	0.60 ± 0.50
Stapler	2.48 ± 0.67	1.65 ± 0.71	1.00 ± 0.52	0.014*

Note: Data are presented as mean ± standard deviation.

^a Comparison between the Xkin and stapler groups at the 12‐week follow‐up (*p < 0.05).

FIGURE 2.

Representative digital photographs of scars at the 2‐, 6‐ and 12‐week follow‐ups.

FIGURE 3.

Comparison of the maximum peak and depth of the scars between the two groups and representative 3D images at the 12‐week follow‐up. (A, D) Photographs of the wound for 3D measurements. All photos were taken under the same conditions. (B, E) The red dots indicate the elevated areas of the scar. (C, F) The blue dots indicate the depressed areas of the scar.

4. DISCUSSION

In addition to the clean recovery of surgical wounds, the cosmetic aspects of the wound are important to patients. The cosmetic appearance of the wound is becoming more important with recent advances in minimally invasive surgery. However, most wound healing studies including cosmetic appearances have been conducted in the areas of plastic surgery or dermatology. Wound healing has not been widely studied in urology, which is at the cutting edge of advances in minimally invasive surgeries.

This is the first study to prove the efficacy of Xkin closure in scar healing and safety through a randomized controlled trial. Our data demonstrate that Xkin is an effective wound closure method for improving scar outcomes. Modified VSS total scores in the Xkin group were significantly superior to the scores in the Stapler group (2.17 ± 1.44 vs. 3.48 ± 1.20, p = 0.002). Furthermore, the vascularity and pliability sub‐scores were significantly superior in the Xkin group compared with the Stapler group. This means that compared to the Xkin group, the surgical wound in the Stapler group was closer to pink than normal in terms of vascularity, and the wound was supple and flexible with minimal resistance. In terms of clinical significance, this means that the wound colour was lighter and more flexible in Xkin group, making it cosmetically excellent. This may have caused by a difference in the inflammatory phase related to scar formation during the stage of wound healing. There may be less pain or itching due to scarring in the long term, and the possibility of developing into keloid or hypertrophic scar may be low. Although it is not a surgical wound, the correlation between mVSS total score and quality of life in burn scar, ²³ and vascularity and liability as predictors of hypertrophic scarring pain outcome have been reported. ²⁴ Additional research involving long‐term data is needed. No significant differences in pigmentation and height were detected, but these scores were lower in the Xkin group compared with the Stapler group. No statistical differences in maximum scar height and maximum valley depth were detected by 3D imaging between the two groups; however, the Stapler group tended to have a larger standard deviation than the Xkin group, suggesting that Xkin is better at forming consistent scars than stapler use. The vascularity sub‐scores, indicating the degree of erythema as a marker of inflammation, were lower in the Xkin group compared with the sub‐scores in the Stapler group. These results suggest that Xkin closure caused less inflammation and was advantageous for uniform scar formation compared with stapler closure. Xkin is a simple and effective wound‐suturing method and is expected to be widely used to treat surgical wounds and lacerations caused by trauma in everyday life.

A previous study of a zip‐style surgical suture device similar to Xkin was conducted in the field of urology. Medizip (Nycomed Pharma GmbH, Ismaning, Germany) was evaluated in 12 patients in the early 2000s by Bastian et al. ²⁵ The target wound was a low midline abdominal wound with a median length of 17.17 cm (range 15.5–18) resulting from an open prostatectomy. Wound dehiscence (2–3 mm) was detected in two patients and one blister beneath the zipper was detected. No other complications were detected. All patients were subjectively very satisfied with the cosmetic results of their wounds. However, the cosmetic results were not objectively evaluated. In our study, cosmetic outcomes were objectively assessed using mVSS and 3D photography.

Rooker et al. ⁴ conducted a prospective randomized study comparing Medizip and intracutaneous sutures skin closure in 120 consecutive patients who underwent various orthopaedic surgeries. Most patients in both the Medizip and intracutaneous groups rated their wounds as “very good” at 6 weeks (82% vs. 85%; p = 0.67). The wound lengths were not significantly different between the Medizip and intracutaneous groups (20.5 ± 9.55 cm vs. 18.2 ± 6.98 cm; p = 0.13), but wound closure time was significantly shorter in the Medizip group (2.1 vs. 9.4 min, p < 0.001). No significant differences in wound closure times were detected in our study, probably because the wound length was relatively short. Wound closure required more time in the Xkin group in the beginning because the surgeon was not familiar with the method; thus, the time required to close wounds with Xkin is expected to be similar or slightly shorter compared to stapler use.

Menkowitz et al. ²⁶ conducted a randomized study comparing zip surgical skin closure to staples in 41 patients who underwent total knee arthroplasty. Cosmesis according to patients and observers was assessed using the Patient and Observer Scar Assessment Scale (POSAS). At 6 weeks, POSAS scores were better for the zip device compared with the scores for staples, including improved colour (p = 0.021), stiffness (p = 0.002), thickness (p = 0.048), vascularity (p = 0.002), pigmentation (p = 0.003), thickness (p = 0.003), relief (p = 0.001), pliability (p = 0.005), surface area (p = 0.002) and observer overall opinion (p = 0.0004). Tian et al. ¹⁴ compared zip‐type skin closure with staple closure in a meta‐analysis, which incorporated six studies and 3550 knees undergoing primary TKAs. Zip‐type skin closure devices caused less pain and lowered medical costs compared with staples.

There are a few limitations to our study. First, this study involved a small number of cases and the follow‐up time was short. This may have caused bias in the research results. However, the number of subjects required to show meaningful results was calculated using statistical methods. Studies with more patients and long‐term follow‐up should be conducted to confirm our results. Second, pain was not assessed using a numeral rating scale or visual analogue scale. We assume that the level of pain was less because the Xkin closure was less invasive, but this outcome was not objectively assessed. Furthermore, this study did not consider the applicable length and area. Xkin can be used on all areas where hydrocolloid can be attached and composed of two sizes: 3 and 5 cm. In the case of longer than 5 cm wound, multiple Xkins can be connected, so theoretically it can be applied to most wounds. However, adhesion may be difficult in environments where hydrocolloids are difficult to attach (for example, wounds where sufficient area of hair has not been removed) or in narrow areas, and these were not considered in the present study. Lastly, cost‐effectiveness was not considered in this study. Xkin costs tens of dollars more than Stapler for the device itself. However, while Xkin allows the patient to self‐remove, it must be taken into account that Stapler requires stitch out, which incurs additional costs, and that stitch out itself, although mild, causes pain. In addition, Xkin, which had a better wound outcome in this study, can be related to less develop into keloid or hypertrophic scar in the long term and may reduce the possibility of additional treatment, so it should be fully considered in terms of cost‐effectiveness. Additional research will be needed on this.

5. CONCLUSIONS

Our results demonstrate that Xkin is an effective wound closure method for improving scar outcomes. Differences in the overall appearance of the wound were demonstrated in the mVSS total score and, in particular, differences in vascularity and pliability among the sub‐scores. As a result of measurement using 3D images, the standard deviation of maximum scar height and maximum valley depth in the Xkin group was smaller than that in the stapler group. The limitation is that staplers are more versatile and can be used in various areas. In terms of cost‐effectiveness, Xkin is more expensive than stapler in terms of device cost, but stitch out cost and pain must be considered as well.

CONFLICT OF INTEREST STATEMENT

The authors have no conflicts of interest to disclose.

ETHICS STATEMENT

This study was approved by the Ethics Committee of Seoul National University Bundang Hospital (IRB No. B‐2208‐776‐001).

INFORMED CONSENT TO PATIENTS

We obtained informed consent from all patients enrolled in the study.

CONSENT FOR PUBLICATION

All authors consent to the publication of this study.

Supporting information

Data S1. Supporting Information.

Jung G, Song SH, Kim BR, Shin JM, Huh C‐H, Lee S. Comparison of the wound healing and complications of zipper type closure adhesive tape and stapler for surgical wound suture: A randomized control, single‐centre, open‐label trial. Int Wound J. 2024;21(7):e70004. doi: 10.1111/iwj.70004

DATA AVAILABILITY STATEMENT

The datasets analyzed during the current study are available from the corresponding author upon reasonable request.