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
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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 13/06/2019
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Miami Chairman and Harvey Blank Professor pays non établi dans la noticeUniversité ou école supérieure
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Orthopedic Foot & Ankle Center pays non établi dans la noticeÉtablissement de santé
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University of California pays non établi dans la noticeUniversité ou école supérieure
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Samuel Merritt University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Scripps Clinic Medical Group pays non établi dans la noticeÉtablissement de santé
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Smith & Nephew (United Kingdom) pays non établi dans la noticeEntreprise
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Dr. Henry Jaimes pays non établi dans la noticeInstitution
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Advanced Foot & pays non établi dans la noticeInstitution
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Global Senior Medical Director—Wounds Smith and Nephew London UK pays non établi dans la noticeInstitution
Chairman and Harvey Blank Professor — University of Miami, Orthopedic Foot & Ankle Center et University of California, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.