Clinical Efficacy and Safety of Theruptor 3-D Composite Microbicidal Dressing in Comparison with Bactigras and Allevyn Dressings on Wound Healing in Participants with Chronic Infected Wounds: A Randomized, Multi-Centric, Comparative, Parallel-Group, Prospective Study.

Abstract

BackgroundAdvanced wound care dressings are vital in managing the complexities of chronic wound treatment. For instance, Theruptor 3-D composite microbicidal dressing is designed with antimicrobial properties to promote wound healing. Despite the availability of several antimicrobial products in the market such as Bactigras, Allevyn, and Aquacel, their comparative efficacy remains unexplored. This study evaluated the clinical efficacy and safety of Theruptor versus Bactigras and Allevyn dressings for chronic wound healing.MethodsA randomized, parallel-group study was conducted from May 2022 to July 2024 across five centres in India. Patients with chronic wounds were randomized to allocate Theruptor, Bactigras, and Allevyn dressings (diabetic and non-diabetic etiology; n = 35 each). Wound area, bacterial load, clinical signs and symptoms, exudate management, and product performance were assessed.ResultsA total of 210 patients with chronic wound in the age range of 19-87 years, were recruited and followed up for 8 weeks. The mean wound area was significantly reduced from Day 0 to Day 56 in in diabetic Theruptor (17.35 ± 15.08 cm² vs 4.13 ± 10.56 cm²), Bactigras (12.93 ± 12.02 cm² vs 3.6 ± 7.75 cm²), and Allevyn (14.36 ± 9.97 cm² vs 0.74 ± 1.65 cm²) and non-diabetic Theruptor (20.45 ± 16.8 vs 3.01 ± 7.52 cm²), Bactigras (18.16 ± 14.81 vs 2.52 ± 5.48 cm²), and Allevyn (28.41 ± 19.97 vs 5.31 ± 9.94 cm²) groups (p < .0001). Further, bacterial load, exudate scores, and clinical signs and symptoms non-significantly improved with time in all three groups (p > .05). In product performance analysis, Theruptor dressing (n = 33/33) was rated more comfortable to wear than Bactigras (n = 24/28, p = .004) and Allevyn (n = 25/30, p = .02) in diabetic patients. Among non-diabetics, more patients reported "no pain" during application and removal of dressing in Theruptor group (n = 26/29 and 28/29) than in Bactigras (n = 18/31; p = .04 and n = 20/31; p = .02) and Allevyn groups (n = 12/29; p = .001 and n = 16/29; p = .003).ConclusionTheruptor provides a safe and effective alternative for chronic wound management with comparable healing outcomes to Bactigras and Allevyn dressings.