Does Topical Wound Oxygen (TWO2) Offer an Improved Outcome Over Conventional Compression Dressings (CCD) in the Management of Refractory Venous Ulcers (RVU)? A Parallel Observational Comparative Study

Abstract

Topical wound oxygen (TWO(2)) may help wound healing in the management of refractory venous ulcers (RVU). The aim of this study was to measure the effect of TWO(2) on wound healing using the primary end-point of the proportion of ulcers healed at 12 weeks. Secondary end-points were time to full healing, percentage of reduction in ulcer size, pain reduction, recurrence rates and Quality-Adjusted Time Spent Without Symptoms of disease and Toxicity of Treatment (Q-TWiST). A parallel observational comparative study. Patients with CEAP C(6,s) RVU, assessed by duplex ultrasonography, were managed with either TWO(2) (n=46) or conventional compression dressings (CCD) (n=37) for 12 weeks or till full healing. Patients were followed up at 3 monthly intervals. At 12 weeks, 80% of TWO(2) managed ulcers were completely healed, compared to 35% of CCD ulcers (p<0.0001). Median time to full healing was 45 days in TWO(2) patients and 182 days in CCD patients (p<0.0001). The pain score threshold in TWO(2) managed patients improved from 8 to 3 by 13 days. After 12-month follow-up, 5 of the 13 healed CCD ulcers showed signs of recurrence compared to none of the 37 TWO(2) healed ulcers. TWO(2) patients experienced a significantly improved Q-TWiST. TWO(2) reduces recurrence rates, alleviates pain and improves the Q-TWiST. We believe it is a valuable tool in the armamentarium of management of RVU.