A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities.

Autor: Kirsner R; Chairman and Harvey Blank Professor, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida., Dove C; Advanced Foot & Ankle Center, Las Vegas, NV., Reyzelman A; Associate Professor, Department of Medicine, California School of Podiatric Medicine at Samuel Merritt University, Co-Director UCSF Center for Limb Preservation, San Francisco, CA., Vayser D; Scripps Clinic Medical Group, Department of Orthopedics/Foot & Ankle Center, Chief, Wound Care Division, San Diego, CA., Jaimes H; Global Senior Medical Director-Wounds Smith and Nephew, London, UK.
Jazyk: angličtina
Zdroj: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society [Wound Repair Regen] 2019 Sep; Vol. 27 (5), pp. 519-529. Date of Electronic Publication: 2019 Jun 13.
DOI: 10.1111/wrr.12727
Abstrakt: Multicenter, phase-4, randomized, comparative-efficacy study in patients with VLUs or DFUs comparing for noninferiority the percentage change in target ulcer dimensions (area, depth, and volume) a single-use negative pressure wound therapy (s-NPWT) system versus traditional NPWT (t-NPWT) over a 12-week treatment period or up to confirmed healing. Baseline values were taken at the randomization visit. Randomized by wound type and size, 164 patients with non-infected DFUs and VLUs were included. The ITT population was composed of 161 patients (101 with VLUs, 60 with DFUs) and 115 patients completed follow-up (64 in the s-NPWT group and 51 in the t-NPWT group) (PP population). The average age for all patients was 61.5 years, 36.6% were women, and treatment groups were statistically similar at baseline. Primary endpoint analyses on wound area reduction demonstrated statistically significant reduction in favor of s-NPWT (p = 0.003) for the PP population and for the ITT population (p < 0.001). Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT. Faster wound closure was observed with s-NPWT (Cox Proportional Hazards ratio (0.493 (0.273, 0.891); p = 0.019) in the ITT population. Wound closure occurred in 45% of patients in the s-NPWT group vs. 22.2% of patients in the t-NPWT group (p = 0.002). Median estimate of the time to wound closure was 77 days for s-NPWT. No estimate could be provided for t-NPWT due to the low number of patients achieving wound closure. Device-related AEs were more frequent in the t-NPWT group (41 AEs from 29 patients) than in the s-NPWT group (16 AEs from 12 patients). The s-NPWT system met noninferiority and achieved statistical superiority vs. t-NPWT in terms of wound progression toward healing over the treatment period. When NPWT is being considered for the management of challenging VLUs and DFUs, s-NPWT should be considered a first choice over other types of NPWT.
(© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje