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      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

      , MD, PhD , 1 , , DPM 2 , , DPM 3 , , DPM, FACFAS 4 , , MD, PhD , 5

      Wound Repair and Regeneration

      John Wiley & Sons, Inc.

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          Abstract

          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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          Most cited references 35

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          Vacuum-assisted closure: a new method for wound control and treatment: clinical experience.

          Despite numerous advances, chronic and other difficult-to-manage wounds continue to be a treatment challenge. Presented is a new subatmospheric pressure technique: vacuum-assisted closure (The V.A.C.). The V.A.C. technique entails placing an open-cell foam dressing into the wound cavity and applying a controlled subatmospheric pressure (125 mmHg below ambient pressure). Three hundred wounds were treated: 175 chronic wounds, 94 subacute wounds, and 31 acute wounds. Two hundred ninety-six wounds responded favorably to subatmospheric pressure treatment, with an increased rate of granulation tissue formation. Wounds were treated until completely closed, were covered with a split-thickness skin graft, or a flap was rotated into the health, granulating would bed. The technique removes chronic edema, leading to increased localized blood flow, and the applied forces result in the enhanced formation of granulation tissue. Vacuum-assisted closure is an extremely efficacious modality for treating chronic and difficult wounds.
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            • Article: found

            Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.

            Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796. More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.
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              Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial.

              The purpose of this study was to evaluate safety and clinical efficacy of negative pressure wound therapy (NPWT) compared with advanced moist wound therapy (AMWT) to treat foot ulcers in diabetic patients. This multicenter randomized controlled trial enrolled 342 patients with a mean age of 58 years; 79% were male. Complete ulcer closure was defined as skin closure (100% reepithelization) without drainage or dressing requirements. Patients were randomly assigned to either NPWT (vacuum-assisted closure) or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. The trial evaluated treatment until day 112 or ulcer closure by any means. Patients whose wounds achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound examination and tracings. A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of 169, 43.2%) than with AMWT (48 of 166, 28.9%) within the 112-day active treatment phase (P = 0.007). The Kaplan-Meier median estimate for 100% ulcer closure was 96 days (95% CI 75.0-114.0) for NPWT and not determinable for AMWT (P = 0.001). NPWT patients experienced significantly (P = 0.035) fewer secondary amputations. The proportion of home care therapy days to total therapy days for NPWT was 9,471 of 10,579 (89.5%) and 12,210 of 12,810 (95.3%) for AMWT. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months. NPWT appears to be as safe as and more efficacious than AMWT for the treatment of diabetic foot ulcers.
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                Author and article information

                Contributors
                rkisner@med.miami.edu
                henry.jaimes@smith-nephew.com
                Journal
                Wound Repair Regen
                Wound Repair Regen
                10.1111/(ISSN)1524-475X
                WRR
                Wound Repair and Regeneration
                John Wiley & Sons, Inc. (Hoboken, USA )
                1067-1927
                1524-475X
                13 June 2019
                Sep-Oct 2019
                : 27
                : 5 ( doiID: 10.1111/wrr.v27.5 )
                : 519-529
                Affiliations
                [ 1 ] Chairman and Harvey Blank Professor, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery University of Miami Miller School of Medicine Miami Florida
                [ 2 ] Advanced Foot & Ankle Center Las Vegas NV
                [ 3 ] Associate Professor, Department of Medicine, California School of Podiatric Medicine at Samuel Merritt University Co‐Director UCSF Center for Limb Preservation San Francisco CA
                [ 4 ] Scripps Clinic Medical Group Department of Orthopedics/Foot & Ankle Center, Chief, Wound Care Division San Diego CA
                [ 5 ] Global Senior Medical Director—Wounds Smith and Nephew London UK
                Author notes
                [* ] Reprint requests: Dr. Robert Kirsner, University of Miami Miller School of Medicine, 1321 NW 14th St, Room 504, Miami, FL, 33125. Tel: +1 305 243 4472;

                Email: rkisner@ 123456med.miami.edu

                Dr. Henry Jaimes, Hatters Lane, Building 5, Croxley Park, Watford, WD18 8YE, United Kingdom.

                Email: henry.jaimes@ 123456smith-nephew.com

                Article
                WRR12727
                10.1111/wrr.12727
                6852528
                31087729
                © 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Figures: 2, Tables: 7, Pages: 11, Words: 8985
                Product
                Categories
                Original Research‐Clinical Science
                Original Research‐Clinical Science
                Custom metadata
                2.0
                September/October 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.1 mode:remove_FC converted:13.11.2019

                Emergency medicine & Trauma

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