OBJECTIVE: A randomized clinical trial was conducted to determine the effectiveness and safety of topical negative pressure therapy in patients with difficult-to-heal wounds. METHODS: A total of 24 patients were randomly assigned to either treatment with topical negative pressure therapy or treatment with conventional dressing therapy with sodium hypochlorite. The study end point was 50% reduction in wound volume. The maximum follow-up time was 6 weeks. RESULTS: The median treatment time to 50% reduction of wound volume in the topical negative pressure group was 2.0 weeks (interquartile range = 1) versus 3.5 weeks (interquartile range = 1.5) in the sodium hypochlorite group (P < 0.001). The unadjusted hazard rate ratio for the time until 50% wound volume reduction was 0.123 (P < 0.001). After adjustment for relevant baseline characteristics in a Cox proportional hazards model treatment group, membership was found as the only and statistically significant indicator for the time to 50% wound volume reduction (hazard rate ratio of 0.117 [P < 0.001]). Subgroup analysis of spinal cord injured patients with severe pressure ulcers showed similar statistically significant results as in the total wound group. CONCLUSION: Topical negative pressure resulted in almost 2 times faster wound healing than treatment with sodium hypochlorite, and is safe to use in patients with difficult-to-heal wounds.
RCT Entities:
OBJECTIVE: A randomized clinical trial was conducted to determine the effectiveness and safety of topical negative pressure therapy in patients with difficult-to-heal wounds. METHODS: A total of 24 patients were randomly assigned to either treatment with topical negative pressure therapy or treatment with conventional dressing therapy with sodium hypochlorite. The study end point was 50% reduction in wound volume. The maximum follow-up time was 6 weeks. RESULTS: The median treatment time to 50% reduction of wound volume in the topical negative pressure group was 2.0 weeks (interquartile range = 1) versus 3.5 weeks (interquartile range = 1.5) in the sodium hypochlorite group (P < 0.001). The unadjusted hazard rate ratio for the time until 50% wound volume reduction was 0.123 (P < 0.001). After adjustment for relevant baseline characteristics in a Cox proportional hazards model treatment group, membership was found as the only and statistically significant indicator for the time to 50% wound volume reduction (hazard rate ratio of 0.117 [P < 0.001]). Subgroup analysis of spinal cord injured patients with severe pressure ulcers showed similar statistically significant results as in the total wound group. CONCLUSION: Topical negative pressure resulted in almost 2 times faster wound healing than treatment with sodium hypochlorite, and is safe to use in patients with difficult-to-heal wounds.