Clinical Research

(CR-030) Comparative Effectiveness of a Bilayered Living Cellular Construct and a Split Thickness Skin Graft for the Treatment of Venous Leg Ulcers

Co-Author(s):

Oscar Alvarez, PhD

Introduction: <span style="font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Using real world evidence (RWE) from a deidentified, wound-specific, electronic medical record database (WoundExpert, Net Health, PA, US), we compared the effectiveness of a bilayer living cellular construct (BLCC) to a split thickness skin graft (STSG) for the treatment of venous leg ulcers (VLUs) in a retrospective comparative effectiveness assessment (CEA) study. Methods: VLUs between the knee and ankle joint that occurred in the presence of venous disease were included. Data from 8,699 refractory VLUs, partial and full thickness, with surface areas between 1 and 20 cm2 in size, treated between September 2011 and September 2021 at 477 wound care facilities across the US were analyzed. All treated VLUs that closed by < 40% within 28 days of the first treatment application were included. Unadjusted time to event analyses were performed by the method of Kaplan-Meier (K-M), and adjusted analyses were performed using Cox’s proportional hazards regression (Cox). Results: <span style="font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Patient baseline demographics and wound characteristics were comparable between groups. Cox derived estimates of wound closure for BLCC (8,124 wounds) was significantly greater than STSG (575 wounds) at week 12 (43 vs. 37%), 24 (65 vs. 57%), and 36 (75 vs. 67%); (p=0.0002). BLCC treatment significantly reduced the median time to wound closure by 18%, achieving healing 3.3 weeks sooner (14.7 vs. 18 weeks; p=0.0002). Treatment with BLCC increased the probability of healing by 24% compared with STSG throughout the period of observation. The Hazard Ratio (HR) = 1.24 <span style="font-size: 12.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">[<span style="font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">95% CI (1.11, 1.39)<span style="font-size: 12.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">]<span style="font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">; p=0.0002. Discussion: <span style="font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">RWE demonstrated that BLCC significantly improved VLU healing compared to STSG. Evidence based treatment algorithms for patients with refractory VLUs are needed to provide guidance to clinicians and payers.
 Trademarked Items: Apligraf, Organogenesis Inc., Canton, MA References: