(WHS-L1.05) VLU WOUND BED PREPERATION IS HIGHLY CORRELATED WITH WOUND CLOSURE - RESULTS FROM THE CHRONEX MULTICENTER RCT
Thursday, May 16, 2024
10:30 AM – 11:30 AM East Coast USA Time
Background Wound bed preparation (WBP) is a critical step in transition of a chronic wound from a disrupted to normal healing process. Debridement of non-viable tissue and promotion of granulation tissue are key components of WBP, that can support secondary healing or facilitate effectiveness of advanced measures. Previously published results from the ChronEx RCT, assessing a novel bromelain-based enzymatic debridement (BBD) in the treatment of chronic venous leg ulcers (VLUs), showed the efficacy of BBD in WBP. The purpose of this analysis was to assess the correlation between WBP and wound closure (WCL). Methods In the ChronEx study patients with chronic VLUs were randomized (3:2:2 ratio) to daily treatment with either BBD, placebo gel vehicle, or non-surgical standard of care (NSSOC), for up to 2 weeks or until reaching complete debridement. Patients were then followed-up weekly with standardized NSSOC for 12 weeks. WBP was defined as complete debridement of non-viable tissue and wound bed completely covered with granulation tissue, both assessed clinically. Complete WCL was defined as complete re-epithelialization of the wound surface without drainage or dressing, confirmed at two visits. The incidence of WCL during the study was compared between those who achieved or did not achieve WBP, in all randomized patients. Incidence of WCL during the follow-up was compared between patients who achieved or not WBP by 16 days (end of daily treatment). The correlation between time to WBP and time to WCL was assessed using a time-dependent proportional hazards Cox regression model. Results A total of 119 patients were randomized to the study, with an average wound size of 15.5 cm2 (SD19.4), average non-viable tissue of 73.2% (SD15.2) and wound present for an average of 31.2 weeks (SD23.9). Overall, 80 patients (67%), reached WBP anytime throughout the study and 39 (33%) did not. Of those that reached WBP, 34 patients (42.5%) achieved WCL within the study period, while only 4 (10.3%) of the patients that did not achieve WBP achieved WCL, with relative risk (RR) of 4.1 (95%CI=1.58-10.85, p=0.0004). Patients reaching WBP by 16 days were 2.2 more likely to achieve WCL within 12 weeks follow-up compared to patients who did not reach WBP by that time, (50.0% vs. 22.7%, 95%CI for RR 1.31-3.71, p=0.0028). Time to WBP correlated with time to WCL (hazard ratio-11.96, 95%CI= 4.24-33.79, p<0.0001). Conclusions The ChronEx study demonstrates that wound bed preparation of chronic VLUs significantly increased the likelihood of complete WCL. These findings support the critical importance of adequate WBP in the process of wound healing. A future phase 3 pivotal study with BBD will utilize these new data to assess the efficacy of this novel treatment in early facilitation of active WCL in VLU.