Use of a Novel Adhesive Suture Retention Device in Lower Leg Excisional Wound Closure: A Retrospective Review

Management of lower extremity excisional wounds can be complicated by the inability of the skin to withstand suturing, thus leading to surgical wound dehiscence (SWD). Surgical wound dehiscence can be a result of suture breakage, poor incisional or flap design, and/or closure under tension.¹ Decreases in dermal collagen integrity occur with age and can result in friable skin that can easily separate with sutures alone.¹ Despite this known complication, primary closure of lower extremity excisional wounds has been shown to have significantly fewer complications than split-thickness skin grafting.² Secondary intention healing has been shown to have better functional and aesthetic outcomes compared with split-thickness skin grafts (STSG) but at the expense of significantly longer healing times.² Secondary healing may take up to 3 months in healthy patients and longer in patients with increased risk factors for poor healing (eg, peripheral edema, venous insufficiency, diabetes).^2,3

Health care spending has increased substantially, with the Centers for Medicare & Medicaid Services projecting health spending to continue to rise to 20.1% of gross domestic product by 2025.⁴ Health care systems are initiating proactive approaches to help mitigate the cost of surgical complications. New and innovative devices that can help curb costs, decrease adverse events, and increase the value of care are a sought-after commodity. Recently launched, the adhesive suture retention device (ASRD) can potentially improve surgical outcomes over the use of glue-based or tape-based products to bolster skin wounds under high tension and allow for uncomplicated linear closure.⁵ This device allows for increased peak suture tension prior to ripping human skin and, in some cases, can be used to close wounds in which the skin had been torn by traditional sutures.⁵ 

This study examined the period of transition from standard of care linear excisional wound closure to ASRD-assisted skin closure in 2 Mohs surgical practices. A retrospective analysis of lower extremity excisional wounds was performed to investigate the effect of adopting the ASRD on rate of wound closure and adverse events such as SWD and infections.

This study was designed as a two-center, retrospective analysis of the management of lower leg wounds before and after adopting ASRD (HEMIGARD ARS Device; SUTUREGARD Medical, Inc). The Samaritan Health Services Institutional Review Board (IRB) in Corvallis, Oregon, reviewed the protocol and determined it to be exempt from further IRB review (IRB20-085).

A retrospective chart review was performed to identify lower leg wound excisions performed for a period of 6 months prior to (July 2019–January 2020) and proceeding (January 2020–August 2020) the adoption of ASRD in the 2 separate clinical sites (Silver Falls Dermatology, Corvallis, OR; and Martinsville Dermatology and Skin Surgery Center, Martinsville, VA). Eligible patients were required to be 18 years of age or older and have full-thickness excisional skin defects at least 1.0 cm in diameter.

Demographic and site-specific details were recorded without any identifying data. The method of closure, time to wound healing, and rate of complications, including dehiscence and infection, were documented. Per historic literature, wound dehiscence was defined as a wound in which exposed dermal or deeper tissue was evident for at least 20% of the length of the suture site.¹ A wound was considered infected if it showed 2 or more clinical signs and symptoms of wound infection per Infectious Diseases Society of America guidelines and/or were prescribed if oral antibiotics were prescribed to treat the surgical site during the observation period. 

All wounds that underwent linear closure prior to ASRD adoption were closed with buried dermal polyglactin sutures, followed by either acrylate glue or interrupted nylon or Vicryl Rapide sutures (Ethicon US, LLC) and butterfly bandages (Steri-Strips; 3M). All wounds that underwent linear closure during the period after ASRD adoption were reapproximated according to the ASRD instructions for use. After minimal tissue undermining, a pair of ASRD strips were adhered to clean, dry skin and a 2-0 nylon retention suture was used (Figure). Additionally, 2 buried dermal polyglactin sutures were used, followed by either acrylate glue or interrupted nylon sutures and butterfly bandages. Patients were asked to keep ASRD dry for at least 5 days. The sutures and ASRD were removed at 2 weeks postoperative.

Statistics

The statistical significance between the cohorts in categorical variables was tested using χ² test and in continuous variables using t tests. All tests were two-tailed with a significance level set at P < .05.

A total of 17 patients were identified in the pre-ASRD cohort and 37 patients in the post-ASRD cohort (Table). There were no significant differences in baseline patient age or sex. A larger proportion of patients in the pre-ASRD group were female (88% pre vs 62% post), but this was not a statistically significant difference (P = .06). The median age was 77.2 years in the pre-ASRD group and 76.6 years in the post-ASRD group (P = .84). Wound sizes were slightly larger in the post-ASRD group, and this difference was statistically significant (Table).

Median time to wound healing was significantly faster for the post-ASRD group at 2.1 weeks compared with 4.3 weeks in the pre-ASRD group (P < .001). Surgical wound dehiscence was significantly more common in the pre-ASRD group (24% vs 3%, P = .03). Infection was also more common in the pre-ASRD group, but the difference was not statistically significant (18% vs 3%, P = .09) (Table). One patient in the post-ASRD group had both SWD and infection. In the pre-ASRD group, 4 patients had SWD, 3 of whom also had an infection.

The data show the use of ASRD was effective in decreasing postoperative complications in patients undergoing linear closure of Mohs surgery in the lower extremity. Results demonstrated favorable clinical outcomes in an older patient population with surgical sites that have a historically high incidence of postoperative complications. The patients who received ASRD in this case review showed statistically significant faster wound healing and a lower frequency of SWD. 

Current options for surgical wound management include secondary intention healing, local tissue flaps, skin grafts, and direct primary closure. Secondary healing often results in months of wound care, which can significantly burden elderly patients and increase overall health care costs. Jung et al⁶ found the average time for reepithelialization of lower extremity wounds after melanoma excision was 12 weeks.

Certain comorbidities can preclude the use of local flaps and grafts. Some surgeons often use the keystone fasciocutaneous flap, which has a more robust blood supply and is often used to close distal lower extremity wounds, but they are prone to lymphedema, flap failure, and contour deformities.⁷ Skin grafts risk donor site morbidity, atrophic scarring, and have significant failure rates on the lower extremity.⁶ A study by Oganesyan et al¹ showed STSGs for lower extremity excisional wounds have a 66% failure rate. 

Although direct linear closure involves less healing time than secondary intention healing and less tissue destruction than flaps and grafts, wound dehiscence and surgical site infection are common postoperative complications.⁸ Surgical wound dehiscence can contribute to significantly increased morbidity and mortality and increased health care cost.^9,10 It has been shown that SWD is the most common postoperative problem encountered in foot and ankle surgery¹¹ and affects up to 39% of lower extremity amputations.¹² 

Advanced age, polypharmacy, and comorbid conditions can adversely affect the integrity of lower extremity skin, often precluding the use of linear closure because the skin tears when placed under the tension required to achieve wound approximation. Risk factors for SWD include patients aged over 65 years, hypertension, invasive surgical procedures, prolonged operative time, wound infection, incision type, suture material, and medical history (obesity, malignancy, lung disease, stroke).¹³ Infection has been shown to be the most significant factor for SWD, likely due to its decreasing of tensile strength.¹³

In this two-center, retrospective study, the adoption of ASRD was associated with an 89% higher rate of linear closures of lower leg excisional wounds and a 51% reduction in time to healed wounds. Despite a trend toward larger wounds in the post-ASRD period, lower leg linear closures with ASRD had less wound dehiscence, and the median time to wound healing was reduced by half. After adoption of ASRD, 1 patient developed both a dehiscence and infection. However, in the pre-ASRD group, 4 patients had dehiscence, 3 of whom also had an infection. Future larger prospective studies will help clarify the extent of reduction in wound complications not only in excisional wound closure but also in incisional wound closure.

There are limitations of this study that should be noted. The retrospective design of this study may serve as a limitation. Further prospective evaluations with randomization of the 2 patient groups would be required to definitively establish a relationship between the use of ASRD and the decrease in SWD. This study evaluated a limited number of patients from only 2 clinical sites. Randomized studies with larger patient sample sizes are needed to solidify conclusions more robustly, although this study can surely act as a pilot for further investigation.

To the authors’ knowledge, this is the only patient cohort study comparing ASRD to standard of care linear incision closure in Mohs surgery of the lower extremity. By curtailing SWD, reducing incision-related antibiotic prescriptions, and effectively decreasing the number of incision-related adverse events, ASRD can potentially lessen the overall cost of care in this patient population. 

Authors: Windy Cole, DPM, CWSP¹; Whitney Fancher, MD²; Allison Stoecker, DO²; Stephanie Howerter, DO³; and William Lear, MD²

Affiliations: ¹Kent State University College of Podiatric Medicine, Independence, OH; ²Silver Falls Dermatology, Corvallis, OR; ³Martinsville Dermatology and Skin Surgery Center, Martinsville, VA

Correspondence: Windy Cole, DPM, CWSP, Kent State University College of Podiatric Medicine, Independence, OH; drwec@yahoo.com 

Disclosure: This study was supported in part by SUTUREGARD Medical, Inc. through the donation of adhesive suture retention devices (HEMIGARD ARS devices). Dr Lear serves as an officer and director at SUTUREGARD Medical and is a shareholder in and co-founder of the company. Drs Stoecker, Fancher, Howerter, and Cole have no relevant affiliations or financial involvement with SUTUREGARD Medical or any organization or entity with a financial interest or conflict with the subject matter or materials discussed in the manuscript.