Defining complete wound closure: Closing the gap in clinical trials and practice

Abstract

We investigate how wound closure is determined in recent randomized controlled wound trials and real-world studies, identify solutions to the current limitations of wound assessment, and propose a standard methodology to define and assess wound healing in research. We searched PubMed for randomized clinical trials using the terms "complete wound closure" and "wound healing rate" and for real-world studies using the terms "real-world wound healing," "real-world wound data," and "wound registries" dating from March 2010 through March 2018. We selected studies that had "complete wound closure" or "healed wound" as an endpoint. Sixty-five trial articles and 10 real-world articles met our criteria, from which we extracted the wound type studied, definition of healed wound used, wound assessment method, the number of weeks assessed, the number of wounds, and the percent of healed wounds in the study group(s) and control group. There were 7,194 trial wounds included. The most common definition of healing used by 26 studies (40.6%) was complete/full/100% (re)epithelialization or closure without discharge, drainage/scab, and/or dressing. Fiftytwo studies (81.2%) used blinded wound assessment, and at least 10 studies (15.6%) used blinded adjudication. The real-world studies analyzed more than 901,396 wounds. Only three studies (33.3%) defined a healed/closed wound, two of which used "complete epithelialization." Eight studies (88.9%) did not define the wound assessment method; none indicated a blinded assessment. We support the Food and Drug Administration definition: 100% reepithelialization of the wound surface with no discernable exudate and without drainage or dressing, confirmed at two visits 2 weeks apart, and we recommend blinded adjudication for wound assessment. The widespread adoption of a standard wound healing definition and assessment method in wound care research would allow for stronger comparisons of treatment effects across studies to improve the evidence base and strengthen the treatment decisionmaking process in clinical practice.

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“…This is consistent with the results of Li, Wang, Wang, Liu, Tang, Liu, Yang, and Zhang 11 . Complete ulcer healing refers to 100% re‐epithelialization or closure without discharge, drainage and scab 43 . Re‐epithelialization occurs when the ulcer is fully granulated and is in the final phase of the proliferative stage 44 .…”

A low incidence of perineal hernia when using a biological mesh after extralevator abdominoperineal excision with or without pelvic exenteration or distal sacral resection in locally advanced rectal cancer patients

“…Table 3 shows wound healing (according to the FDA definition of a completely healed wound [ 16 ]) and wound complications following surgery with Permacol™ mesh closure. The wound was healed within 30 days after surgery in 2 patients (5.7%) and within 3 months after surgery in 11 patients (31.4%).…”

“…The treatment of wound complications was divided into five groups with conservative treatment, antibiotics, vacuum-assisted closure (VAC), surgical re-intervention or a secondary lotus petal flap reconstruction as possible treatment options. The following United States Food and Drug Administration (FDA) definition of complete wound healing was used: 100% re-epithelialization of the wound surface with no discernable exudate and without drainage or dressing requirement, confirmed at outpatient clinic visits [ 16 ]. A computed tomography (CT) scan was used in the follow-up of these rectal cancer patients and also to detect perineal hernia.…”

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