T2 One Year Follow up Results of the DETECT Enzymatic Debridement Multicenter RCT

Abstract Introduction Bromelain Based Debridement (BBD) of deep thermal burns has been approved for use in Europe, Argentina, Russia, South Korea, Peru, and Israel, and is an investigational product in the United States. Topline results of acute stage endpoints of the DETECT Phase 3 multicenter RCT have been reported previously. The aim of this abstract is to present the 12-month follow-up of predefined endpoints of scar quality, function and quality of life (QoL). Methods One-hundred and seventy-five adult patients with deep burns were randomized in a Phase 3 clinical trial to one of 3 treatment arms – BBD, Standard of Care (SOC), or Gel vehicle (placebo control) in a 3:3:1 ratio (75 BBD, 75 SOC, and 25 Gel). Scar quality (cosmesis) and function data were analyzed for longer-term data collected at 3, 6, 12 (and 24 - data not yet final) months. Cosmesis and function were measured using Modified Vancouver Scar Scale (MVSS) and Patient and Observer Scar Assessment Scale (POSAS) to demonstrate that BBD treatment was non-inferior to SOC treatment, as measured at 12 months from wound closure date, evaluated by assessors blinded to the treatment arm. QoL was measured by the EQ-5D (EuroQol 5 Dimensions), VAS (Visual Analog Scale) and BSHS-B (Burn Specific Health Scale – Brief) scales. Missing values were imputed in the analysis using multiple imputation, with best case-worst case imputations as sensitivity analyses. Results The 12-month follow-up mean MVSS scores were lower (better) for the BBD group (3.70±2.10) than for the SOC (5.08±3.11) and Gel groups (5.63±2.99). A regression analysis showed that BBD has a 1.36 MVSS point advantage over SOC after adjustment for all other variables in the model (p-value = 0.0027). The 95% CI for this treatment effect was -2.24 to -0.48, excluding the pre-defined non-inferiority margin of +1.9 points, thus establishing non-inferiority of BBD treatment compared with SOC. Note that the interval also excludes 0, indicating superiority of BBD over SOC. The 3- and 6-month follow-up MVSS scores are also lower for the BBD group (5.51±3.09, 4.43±2.59) than for the SOC (6.63±3.44, 5.43±3.75) and Gel (7.56±2.67, 8.89±3.37) groups. POSAS total scores followed similar trends to MVSS scores but did not reach statistical significance at 12 months. QOL was generally similar among the treatment arms. Conclusions In addition to the significant acute stage results presented previously, the long-term results of this RCT further demonstrate the safety of BBD treatment, including significantly better 12-month follow-up MVSS scores.

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