Noninvasive Skin Closure Device (DermaClip®) vs Conventional Sutures: A Randomized Crossover Trial on Cadaver Models

Introduction Lacerations comprise one of the leading causes of disease non-battle injuries encountered both stateside and during deployment. These injuries cause a significant impact on mission accomplishment and readiness, requiring extended time to repair and personnel to manage. The purpose of this study is to compare conventional sutures to the DermaClip^® noninvasive skin closure device (DermaClip US, LLC, Houston, TX, USA) on cadaver models. The hypothesis is that there will be a difference in the time of skin closure between DermaClip^® and sutures. The primary outcome of the study is to compare the time of skin closure between the two methods, while the secondary outcomes will assess the efficacy and user confidence for each method. Methods We conducted this study in the Medical Simulation Training Center (MSTC) cadaver lab at Fort Hood, TX, USA. The study was performed during a biannual cadaver procedure lab on five unembalmed, fresh-frozen cadavers. The UTHealth Houston provided cadavers previously donated by the decedent before death or by the decedent's family. We recruited volunteers from the Carl R. Darnall Army Medical Center ED residents, staff physicians, and students participating in MSTC training. Volunteers received a block of instruction on the placement of the DermaClip^® skin closure device from the manufacturer's website. Investigators randomly assigned volunteers to two groups and timed skin closure utilizing DermaClip^® or conventional sutures. A study team member verified the skin closure and assigned a grade utilizing the 6-point Hollander Wound Evaluation Scale. Volunteers were also asked to complete a survey to rate the confidence and efficacy of each method. Results Twenty participants performed 40 laceration repairs using either the DermaClip^® or conventional sutures. They conducted 20 repairs using DermaClip^® and 20 using conventional sutures. Our results demonstrated a significant time difference in skin closure time, favoring the DermaClip^® device over conventional sutures (77 seconds vs 456 seconds, P = 0.001). Conclusions This study sought to detect whether a significant difference in time to skin closure exists between DermaClip^® and conventional sutures. Secondarily, we sought to evaluate efficacy and confidence. Following analysis, DermaClip^® demonstrated significantly less time to skin closure. However, although participants rated DermaClip^® higher in efficacy and confidence, the results were not significant. Further studies are required, preferably on live patients with a cost analysis, to determine if DermaClip^® is superior to conventional sutures.