TY - JOUR
T1 - 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
AU - Kirsner, Robert
AU - Dove, Cyaandi
AU - Reyzelman, Alex
AU - Vayser, Dean
AU - Jaimes, Henry
N1 - Funding Information:
Dr Alexander Reyzelman, DPM, Center for Clinical Research, San Francisco CA; Dr Robert Kirsner, MD, University of Miami Department of Dermatology, Miami, FL; Dr Cyaandi Dove, DPM, Advanced Foot and Ankle Center, Las Vegas, NV; Dr Joseph Cavorsi, Center for Advanced Wound Care, Wyomissing, PA; Dr Joseph Caporusso, DPM, Futuro Clinical Trials, McAllen, TX; Dr Robert Galiano, MD, Northwestern University, Feinberg School of Medicine, Chicago, IL; Dr Dean Vayser, DPM, ILD Consulting, Carlsbad, CA; Dr Travis Motley, DPM, Acclaim Bone & Joint Institute, Fort Worth, TX; Dr Jane Yang, MD, Olive View-UCLA Medical Center, Sylmar, CA; Dr Stephanie Wu, DPM, Center for Lower Extremity Ambulatory Research, Chicago, IL; Dr Bradley Lamm, DPM, and Dr Norman Siddiqu, DPM, Rubins Institute for Advanced Orthopedics ? Sinai Hospital, Baltimore, MD; Dr John Clements, DPM, Carillion Clinic, Roanoke, VA; Dr Noah Oliver, DPM, Ochsner Clinic Foundation, New Orleans, LA; Dr Emily Oji, MD, Valley Foot & Ankle Speciality Providers, Fresno, CA; Dr Xingbo Sun, DPM, The Sun Healthcare & Surgery Group, Martinez, CA; Dr Christina Morin, DPM, Centre Podiatrique et Soins de Plaies, Boucherville, QC, Canada; Dr Perry Mayer, MD, The Mayer Institute, Hamilton, ON, Canada.
Publisher Copyright:
© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - 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.
AB - 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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U2 - 10.1111/wrr.12727
DO - 10.1111/wrr.12727
M3 - Article
C2 - 31087729
AN - SCOPUS:85067655387
VL - 27
SP - 519
EP - 529
JO - Wound Repair and Regeneration
JF - Wound Repair and Regeneration
SN - 1067-1927
IS - 5
ER -