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.
Subject(s)
Lacerations , Soft Tissue Injuries , Female , Humans , Male , Lacerations/therapy , Pain , Pain Measurement , SuturesABSTRACT
INTRODUCTION: Effective approaches to increase engagement in treatment for opioid use disorder (OUD) and reduce the risk of recurrent overdose and death following emergency department (ED) presentation for opioid overdose remain unknown. As such, we aim to compare the effectiveness of behavioural interventions delivered in the ED by certified peer recovery support specialists relative to those delivered by licensed clinical social workers (LCSWs) in promoting OUD treatment uptake and reducing recurrent ED visits for opioid overdose. METHODS AND ANALYSIS: Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD) (n=650) will be recruited from two EDs in a single healthcare system in Providence, Rhode Island into a two-arm randomised trial with 18 months of follow-up postrandomisation. Eligible participants will be randomly assigned (1:1) in the ED to receive a behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW. The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records. ETHICS AND DISSEMINATION: This protocol was approved by the Rhode Island Hospital institutional review board (Approval Number: 212418). Data will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03684681.