Abstract
BACKGROUND: microMend, a novel microstaple skin closure device, may be able to close simple lacerations. This study aimed to evaluate the feasibility and acceptability of using microMend to close these wounds in the ED. METHODS: This was an open-label, single-arm clinical study conducted at two EDs within a large urban academic medical centre. Wounds closed with microMend underwent assessments performed at days 0, 7, 30 and 90. Photographs of treated wounds were rated by two plastic surgeons using a 100 mm visual analogue scale (VAS) and a wound evaluation scale (WES), which has a best possible score of 6. Participants rated pain during application and both participants and providers rated their satisfaction with the device. RESULTS: Thirty-one participants were enrolled in the study: 48% were female and the mean age of participants was 45.6 (95% CI 39.1 to 52.1). The mean wound length was 2.35 cm (95% CI 1.77 to 2.92), with a range of 1-10 cm. Mean VAS and WES scores at day 90 as evaluated by two plastic surgeons were 84.1 mm (95% CI 80.2 to 87.9) and 4.91 (95% CI 4.54 to 5.29), respectively. The mean pain score with application of the devices was 7.28 mm (95% CI 2.88 to 11.68) on a scale of 0-100 mm using VAS. Local anaesthesia was used in 9 patients (29%, 95% CI 20.7 to 37.3) of participants (of whom 5 required deep sutures). Ninety per cent (90%) of participants rated their overall assessment of the device as excellent (74%) or good (16%) at day 90. There were no serious adverse events in any participants in the study. CONCLUSION: microMend appears to be an acceptable alternative for closing skin lacerations in the ED, providing good cosmetic results, with high levels of satisfaction by patients and providers. Randomised trials are needed to compare microMend with other wound closure products. TRIAL REGISTRATION NUMBER: NCT03830515.