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Zip Stitch Longmed Wound Closure Device Randomized Study

Randomized Study of a New Noninvasive Zip Stitch Skin Closure Device for Use After Congenital Heart Operations

Yuki Tanaka, MD, Takashi Miyamoto, MD, PhD, Yuji Naito, MD, PhD,

Shuichi Yoshitake, MD, Akihiro Sasahara, MD, and Kagami Miyaji, MD, PhD

Department of Cardiovascular Surgery, Gunma Children’s Medical Center, Shibukawa; and Department of Cardiovascular Surgery,

Kitasato University Hospital, Sagamihara, Japan

Longmed Non-invasive Wound Closure Device Band Aid Laceration Kit

Background：

We report a new Zip Stitch Longmed noninvasive wound closure device (ZheJiang Longmed Medical Technology Co.,Ltd.,).This device is considered to have good cosmetic outcomes after operations and reduces surgical time. In this study,skin closure using the Closure device was compared with subcuticular sutures and the usefulness and safety of this new device was evaluated.

Methods：

This was a prospective, randomized study of 214 patients who underwent cardiac operations through a median sternotomy from June 2014 to December 2015. In 136 patients, this was a first operation group of which 71 patients underwent wound closure device (Closure group), and 65 patients underwent sub-cuticular sutures (suture group). In 78 patients, this was a reoperation group, of which 42 patients were in the Closure group and 36 patients were in the suture group.Cosmetic results using the Vancouver Scar Scale were evaluated separately in the first operation group and reoperation group.

Results:

There were significant differences in the total Vancouver Scar Scale score between the first operation group (p < 0.001) and reoperation group (p [ 0.007). The skin closure time was significantly shorter in the Closure group than in the suture group (113.0 ± 9.1 seconds vs375.9 ± 60.2 seconds, p < 0.001). No significant differences were found regarding the rate of surgical site infection between the groups. Complications peculiar to this device included skin discoloration(0.9%), epidermolysis (0.9%), and exfoliation of the device (1.8%); however, no serious complications developed.

Conclusions:

In congenital heart operations through a median sternotomy, the wound closure device was an excellent choice for improving the cosmetic appearance and reducing the wound closure time. In addition, it proved to be a device that could be used safely.

(Ann Thorac Surg 2016;102:1368–74) 2016 by The Society of Thoracic Surgeons

Surgical site infections and hypertrophic scars are the major post surgical wound complications, and these sometimes can occur after cardiovascular operations [1–3]. The use of several skin closure devices, such as cyanoacrylate glue and surgical staples, has been reported [4–6], and these devices have been demonstrated to have good potential in reducing skin closure time,improving cosmetic appearance, and decreasing infection rate. The wound closure device (ZheJiang Longmed Medical Technology Co.,Ltd.,) is a new,noninvasive final layer skin closure device that decreases the potential for wound complications [7, 8].

The development concept of Zip stitch Longmed wound closure device was to shorten the skin closure time and prevent a hypertrophic scar after the operation. Although closure device use has been reported in fields other than Cardiovascular surgery, there are no reports of the wound closure device being used to close surgical wounds of congenital patients in whom a median sternotomy was performed. In this study, we evaluated whether wound closure device is a useful and safe device to close surgical incisions in congenital patients after cardiovas-cular operations through a median sternotomy.

 

Accepted for publication March 23, 2016.

Address correspondence to Dr Tanaka, Department of Pediatric Cardiac Surgery, Gunma Children’s Medical Center, 779 Shimohakoda,Hokkitsumati, Shibukawa, Gunma 377-8577, Japan; email: [email protected].

2016 by The Society of Thoracic Surgeons 0003-4975/$36.00 Published by Elsevier

 

Patients and Methods

The research protocol for this wound closure device study was approved by the Study Review Board at our institution in accordance with the Declaration of Helsinki.

Patients and Study Design

The wound closure device study included 238 patients who consecutively underwent cardiac operations through a median sternotomy from June 2014 to October 2015 at the Department of Cardiovascular Surgery of Gunma Children’s Medical Center in Shibukawa, Japan. Enrolled patients were randomly assigned to a wound closure device group(Closure group) or a subcuticular suture group (suture group)using computed simple randomization and were studied prospectively (Fig 1). All patients provided written informed consent to participate.

Patients who had undergone delayed sternal closure and those who had a chromosomal abnormality other than trisomy 21 were excluded from the study to simplify the evaluation in this trial. The study excluded 20 patients who had a delayed sternal closure, 1 patient who had a chromosomal abnormality other than trisomy 21, and 3 patients who died within 3 months of their operation, leaving 214 patients in this study.Reoperation patients and those with trisomy 21 were included.

Demographic data and clinical characteristics were collected that included gender, age, body weight, whether the patient had Down syndrome or was an infant or a neonate, length of the surgical wound, total operation time, and amount of bleeding. The outcomes analyzed in this study included cosmetic appearance, skin closure time, and complication rate.

The 214 patients were divided into a first operation (FO) group or a reoperation (RO) group, and each group was analyzed for cosmetic appearance. However, all patients were pooled to compare the skin closure times and complication rates between the Closure group and suture group. In advance, we analyzed potential complications peculiar to the wound closure device,which included skin discoloration, epidermolysis,allergicreaction to the device, and

damage to and exfoliation of the device. These complications were analyzed based on the information provided by the company and personal experience, and damage of the device was also included to evaluate the safety of the device.

Zhejiang Longmed Zip Stitch Wound Closure Device

Device and Technique

The 214 patients included in this study underwent cardiovascular operations through a median sternotomy, with or without a cardiopulmonary bypass. In both the closure and suture groups, subcutaneous tissues were sutured using 4-0 Vicryl (Ethicon, Cincinnati,OH) absorb-able multifilament sutures. In Closure group, the outermost surface of the surgical wound was closed with the wound closure device (Fig 2). In the suture group,continuous subcuticular sutures were conventionally placed using 5-0 Prolene sutures (Ethicon) with the surgical clip on the end of a suture.

Wound protection was achieved using sterilized gauze, which was replaced with new gauze, without disinfectant,in case it was stained with sweat or effusion. In all patients, removal of the device or removal of stitches occurred 7 days after the operation. Removal of the wound closure device was achieved using an adhesion remover (Nichiban, Bunkyo, Tokyo, Japan) to protect the skin. After removal of the device or stitches,patients were allowed to take a bath.

Longmed Skin Closure Device

Follow-Up and Data Collection

Electronic medical records and the Japanese congenital cardiovascular surgery database were used as tools to record clinical data. All demographic data and clinical characteristics data were recorded preoperatively and intraoperatively. Skin closure times were recorded intraoperatively with a stop watch. The wound management protocol was applied to all patients. Follow-up and com plications data were collected by 3 cardiovascular surgeons at 1, 2, 4, 8, and 12 weeks post operatively. The cosmetic appearance was recorded at 3 months postoperatively. Once discharged, patients were followed up as outpatients at our institution.

Wound Assessment

Assessment of cosmetic outcomes was performed by 2 plastic surgeons 3 months after the operation who were blinded to the type of skin closure used. The cosmetic appearance was assessed using the Vancouver Scar Scale (VSS), a widely recognized burn scar assessment scale that was first described by Sullivan in 1990. The VSS is the most frequently used assessment scale for surgical scars [9–11] and has four categories based on vascularity, pigmentation, pliability, and height [12]. The total score ranges between 0 and 13, where a score of 0 reflects normal skin (Table 1).

Table 1 Categories and Scores of the Vancouver Scar Scale

Statistical Methods

StatView 5.0 software (SAS Institute Inc, Cary, NC) and Excel 2013 (Microsoft Corp, Redmond, WA) were used for data analysis. Results are presented as the mean SD or median and interquartile range with 95% confidence intervals for quantitative variables, and categoric variables are summarized by absolute frequencies and percentages. Continuous variables were compared using the student test and Mann-Whitney U test. Categoric variables were compared using the Pearson X² test or with the Fisher exact test when expected frequencies were less than 5. P values of 0.05 or less were considered to be statistically significant.

 

Results

The FO group had 136 patients (Closure group: 71 patients;suture group: 65 patients) and the RO group had 78 patients (Closure group: 42 patients; suture group: 36 patients).Our outpatient department monitored all patients for more than 3 months after their cardiac operation. Analysis of demographic data and clinical characteristics showed there were no significant differences between the group and the suture group (Table 2). There was also no significant difference in the total mean VSS scores in the RO group preoperatively (Closure: VSS 3.2  1.2; suture:VSS 3.3 1.3; p ¼ 0.57). Mean age and body weight were higher in the RO group compared with the FO group, and the mean total operation time was longer in the RO group, although these results were not significant.

 

Cosmetic Appearance

Cosmetic appearance was assessed by the VSS 3 months after the operation (Fig 3). In the FO group, the VSS of the Closure group was significantly lower than the suture group for all VSS variables (Table 3). In the RO group, vascularity, pigmentation, and the total VSS score were significantly lower in the Closure group than in the suture group. In addition, the total VSS score in patients with trisomy 21 was significantly lower in the Closure group compared with the suture group (Table4).Furthermore,the total VSS score in infants was significantly lower in the Closure group than in the suture group (Table 5). Simi-larly, in neonates, the total VSS score of the Closure group was significantly lower than that of the suture group (3.0  2.0 vs 5.2  2.3, p < 0.017). There were no significant differences in VSS scores for wound closure (p ¼ 0.96)and suture (p ¼ 0.79) between the 2 surgeons.

 

Wound Closure Device Skin Closure Time

The difference in the total operation time between the Closure group and the suture group (340.3  127.1 minutes vs328.2  120.7 minutes) was not significant (p ¼ 0.70).However, the skin closure time in Closure group was significantly shorter than that in the suture group (113.0  9.1 seconds vs 375.9  60.2 seconds, p <0.001; Fig 4). The median skin closure times were 113 seconds (range, 98 to135 seconds) in the Closure groupand 389 seconds (range, 256to 470 seconds) in the suture group.

Table 2 Patient Demographics and Clinical Characteristics

Complications and Physical Findings

The complication rate was compared between Closure group (n ¼ 113) and the suture group (n ¼ 101). Surgical wound infection occurred in 1 patient in Closure group and in 2 patients in the suture group. The rate of surgical infection was not significantly different between Closure group and the suture group (0.9% vs 2.0%, p ¼ 0.50).Three patients had surgical site infections that were not severe and they improved with antibiotics and washing with a salt solution. Surgical wound dehiscence occurred in 2 patients in Closure group and in 3 patients in the suture group. There was no significant difference in surgical wound dehiscence between the two groups (1.8% vs 3.0%, p ¼ 0.56). All patients in whom wound dehiscence occurred were neonates or with trisomy 21.Complications occurring that are peculiar to Closure device included skin discoloration (0.9%), epidermolysis (0.9%), and exfoliation of the device (1.8%). Discoloration occurred due to the eruption of the adhesive tape, which was improved by the application of a steroid ointment. Epidermolysis was also treated with the ointment. New devices were affixed in patients whose devices peeled off.

However, no serious complications developed, such as an allergy to or damage to the devices. We could not assess pruritus or pain because our pediatric patients, who included infants, could not complain of these symptoms.

However, during the removal of wound closure device or stitches,significantly fewer patients cried or complained in Closure group compared with the suture group (7.1% vs 52.5%, p < 0.001).

Longmed Wound Closure Device
Table 3. Cosmetic Appearance Outcomes Based on the Vancouver Scar Scale
Table 4. Cosmetic Appearance Outcomes in Patients With Trisomy 21 Based on the Vancouver Scar Scale
Table 5 Cosmetic Appearance Outcomes in Infants Based on the Vancouver Scar Scale
Wound Closure Time

Comment
This study is the first randomized controlled trial of the wound closure device in pediatric patients who underwent cardiac operations. Although some recent case reports associated with the wound closure device have been presented, none reported cardiac operations through a median sternotomy [7, 8]. Also, the benefits or complication risks in pediatric patients remain unknown. In our study, we evaluated pediatric patients who had undergone cardiac operations through a median sternotomy. Our results demonstrated a significantly better outcome in the Closure group compared with the suture group.Given that a number of factors affect the cosmetic appearance of surgical wounds, such as the use of electrocautery, infection, approach, and suture material [13–15], we used a consistent surgical incisional approach and suture material, and electrocautery was used to perform the median sternotomy in all patients. Our re sults demonstrated that the wound closure device has cosmetic benefits, regardless of whether it was a first operation or a reoperation. In pediatric cardiac surgery, many patients have trisomy 21 [16]. Furthermore, for pediatric patients who have cardiac defects, cardiacoperations are often performed during infancy [17, 18].

On the basis of the results of this trial, we believe that this wound closure device can be successfully used in a wide range of patients.
In terms of closure time, surgical wounds closed using the wound closure device had an obviously excellent performance compared with wound closure using sutures. Similarly, the use of 2-octylcyanoacrylateglue can also reduce surgical wound closure time [4, 19]. However, there are no reports in which octylcyanoacrylate has been used for a median sternotomy, making comparisons of its safety and closure times to the wound closure device difficult. In this study, the
temporal dispersion of skin closure time in the Closure group was exceedingly small, meaning that use of this device was not affected by the length of the wound or by different surgeons. Therefore, the longer the wound, the greater relative benefit can be expected.
Although the difference in the surgical wound infection rate between the Closure group and the suture group was not significant, fewer wound infections occurred in the Closure group. The incidence of surgical site infection after pe-diatric cardiac operations has been reported to range from 2.3% to 8% [20–23]. In this study, the incidence of postsurgical wound infection in the Closure group was 0.9%,which is an extremely low infection rate considering that there was no remnant in the epidermis in the Closure group.The use of silicone gel to prevent surgical wound infections or hyper trophic scars has been presented [24–26].However, the wound closure device has the added benefit of shortening the wound closure time
in addition to preventing surgical wound infections and surgical scars.

Similar to the wound infection rate, the surgical wound dehiscence incidence rate in the Z group was equal to or greater than the suture group. However, the wound closure device has greater flexibility for wound dehiscence and is more noninvasive. We removed the suture or the device 7 days after the operation in accordance with study design. However, we consider that removal of the device should be performed depending on the wound condition in neonates and patients with trisomy 21 because wound dehiscence was observed in these patients only. Complications peculiar to the device include skin discoloration, epidermolysis, and exfoliation of the device, although none occurred at a high rate or were serious. Consequently, we concluded that the wound closure device can be used safely.
A superior feature of the wound closure de-vice is the ability to adjust its length and tension. The length of the device can be easily adjusted by cutting the device at the appropriate point. The tension of the device can be adjusted without limit because of the adapting strap-rock system. For example, the tension of the device can be adjusted multiple times according to the extent of edema or wound healing after the operation. Furthermore, the degree of wound healing can be confirmed by disconnecting the zippers. Thus, the device can accommodate dehiscence by rocking the zipper again, without the need for sutures.

From the results from this study, we believe that the greatest advantages of using the wound closure device are the good cosmetic appearance and reduced closure time. Also, the safety of the device was as good as subcuticular sutures. However, a distinctive feature of the wound closure device was that it was less painful when removed, making it particularly beneficial for pediatric patients. In fact, significantly fewer patients in the Closure group had pain or cried during removal of the device or stitches compared with the suture group.Conversely, the cost performance of the wound closure device is not as good as sutures. The cost of wound closure device is $85, which is approximately three-times higher than that of subcuticular suture.However, we consider that this device is well worth using based on its cosmetic and closure time effectiveness.

The present study has several limitations. Firstly, this study was conducted in a single institution; therefore, generalization of our results is limited. However, these data are important because this is the first prospective randomized trial reporting the use of the wound closure device in pediatric patients who underwent amedian sternotomy.

Secondly, the number of patients with Down syndrome is relatively small, resulting in insufficient statistical power to evaluate the efficiency of the device in the Down syndrome population.

Thirdly, the study excluded patients with a chromosomal abnormality, except trisomy 21, and patients who had a delayed sternal closure. Thus, we could not examine outcomes in those populations. Regarding device and technique, continuous subcuticular suturing using nonabsorbable polypropylene sutures with removal of sutures may be a rare method.Finally, this study was a randomized trial of pediatric patients and we did not examine the efficiency in adult patients. Therefore, a prospective, randomized clinical trial in adult patients is required to validate the use of the device in the adult population.

In conclusion, this is the first randomized trial to evaluate the outcomes of the zip stitch Longmed wound closure device in pediatric patients who underwent cardiac operations via a median sternotomy. Our study showed that the device has an excellent performance in improving the cosmetic appearance and reducing skin closure times. It is a noninvasive device that can be used simply and safely and may be suitable for pediatric patients because it is less painful.

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