(WHS-P2) COMPARISON OF BROMELAIN-BASED ENZYMATIC DEBRIDEMENT TO COLLAGENASE SATYL® OINTMENT - ANALYSES FROM THE CHRONEX MULTICENTER RCT
Friday, May 17, 2024
7:30 AM – 5:00 PM East Coast USA Time
Background Results from the ChronEx RCT, assessing a novel bromelain-based enzymatic debridement (BBD) in the treatment of chronic venous leg ulcers (VLU) were published previously. BBD was superior to hydrogel placebo and non-surgical standard of care (NSSOC), in complete debridement (CD) and complete granulation (CG), key components of wound bed preparation (WBP). One of the NSSOC used in the study was collagenase Santyl® Ointment, approved in the US for debridement of chronic dermal ulcers. Post-hoc analyses assess the efficacy of BBD vs. Santyl in VLU in ChronEx. Methods In ChronEx patients with chronic VLU were randomized (3:2:2 ratio) to daily treatment with BBD, placebo, or NSSOC, for up to 2 weeks or until reaching CD and then followed-up weekly with NSSOC for 12 weeks. NSSOC included Santyl, hydrogels, medical grade honey, and non-active dressings. Surgical or mechanical debridement were not allowed. Post-hoc analyses assessed incidence and time to CD, CG and WBP in patients treated with BBD compared to Santyl, placebo, and NSSOC excluding Santyl (NSSOCES). WBP was defined as CD and CG, both assessed clinically. Log-rank test was used to compare survival distributions and Fisher Exact test to compare incidences. Summary of results Of the 119 patients randomized, 46 were treated with BBD, 43 with placebo and 30 with NSSOC. Of the NSSOC arm, 8 patients were treated with Santyl and 22 were treated with NSSOCES. Overall, the average wound size was 15.5 cm2 (SD19.4), average non-viable tissue 73.2% (SD15.2) and average wound age 31.2 weeks (SD23.9). Baseline characteristics were comparable across all groups . Median time to complete debridement (95% CI) was 9 days (5-15 days) for BBD vs.not achieved for Santyl (22-NA, P=0.023), 63 (21-93) and 44 days (21-67) on placebo and NSSOCES respectively. Incidence of CD (95% CI) during the two weeks daily treatment was 63.0% (47.5-76.8) for BBD vs. 0% for Santyl (p=0.001), 30.2% (17.2-46.1) and 18.2% (5.2-40.3) for placebo and NSSOCES respectively. Median time to CG as well as to WBP (95% CI) was 11 days (7-50 days) for BBD vs. not achieved for Santyl (22-NA, P=0.014), 85 (24-99) and 61 days (30-85) on placebo and NSSOCES respectively. Incidence of WBP (95% CI) during the study was 78.3% (63.6-89.1) on BBD vs. 37.5% on Santyl (8.5-75.5, P=0.03), 60.5% (44.4-75.0), and 68.2% (45.1-86.1) on placebo and NSSOCES respectively. Conclusions Debridement of non-viable tissue and promotion of a well vascularized granulation tissue are key components of WBP, that can support secondary healing or facilitate the effectiveness of other advanced measures. Analysis from the ChronEx RCT demonstrates a clinically meaningful and statistically significant reduction in time to CD, CG and WBP and increased incidence of WBP in VLU patients treated with BBD compared to those treated with Santyl.