Compression versus bridge negative pressure wound therapy combined with compression in non-healing venous ulcers: A randomized controlled trial with quality-of-life assessment and cost effectiveness

ObjectivesNegative pressure wound therapy (NPWT) is a useful adjunct to optimization of wound healing. We aimed to evaluate the benefits of NPWT in the management of refractory non-healing venous leg ulcers (VLU), in conjunction with compression therapy (CT).MethodsA randomised controlled trial where 50 patients with chronic VLU were randomised to either NPWT with CT, or to CT alone, on a 1:1 ratio, for 12 weeks. Sample size was calculated to detect a minimum of 19 days with a standard deviation of 12 days and a power of 95% (α = 5%). Patients were followed-up for 1 year. Patients with mixed aetiology were excluded.ResultsDemographics, risk factors were similar in both groups. All ulcers were CEAP C_6,s.Mean time to full healing was 64.3 days ±4.2 days in NPWT + CT patients and 83.2 days ±8.4 days in compression patients (<i>p</i> < .001). At 12 weeks, 80% of NPWT + CT managed ulcers (<i>n</i> = 20/25) were completely healed, compared to 36% of CCD ulcers (<i>n</i> = 9/25) (<i>p</i> < .001). Mean reduction in ulcer surface area at 12 weeks was 79% in NPWT + CT patients, compared to 58% in the compression group (<i>p</i> < .001). At 12 months follow-up, one recurrence occurred in the NPWT group, compared to two of the compression healed ulcers (<i>p</i> = .375). No local or systemic complications were encountered in either treatment group. NPWT + CT participants experienced an improvement in their physical functioning component. Total cost was 80,187.50 euros for NPWT + CT as opposed to 88,135.00 euros for CT participants.ConclusionsNPWT reduces healing time, improves wound size reduction, reduce bacterial colonization in VLUs and enhances patient quality of life compared to compression alone. It achieves this while being cost-neutral compared to compression therapy alone with better quality of life by reducing complications and hospital stays.