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The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study).

ABSTRACT: BACKGROUND:Although the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of negative-pressure wound therapy (NPWT) can reduce the healing period for many types of wounds. Herein, we describe a planned trial to test the hypothesis that NPWT can reduce the healing period for PSC after stoma reversal. METHODS/DESIGN:Patients undergoing stoma reversal will be recruited and allocated into intervention and control groups, with 1:1 randomisation. Patients in the control group will receive standard postsurgical wound care; patients in the intervention group will receive NPWT using the PICO™ system. The target sample size will be 38 patients, as this will provide 80% power at the 5% level of significance to detect a 7-day reduction in the wound-healing period in the intervention group compared to that in the control group. The primary endpoint will be the duration to wound healing, defined as the time to nearly complete epithelisation of the wound, without any discharge or surgical site infection (SSI). Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores. DISCUSSION:The results of this planned randomised controlled study will clarify the role of NPWT in patients undergoing stoma reversal and strengthen the rationale for choosing a dressing technique. TRIAL REGISTRATION:Clinical Research Information Service (CRIS), KCT0004063. Registered on 6 June 2019.

SUBMITTER: Kim S

PROVIDER: S-EPMC6945515 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study).

Kim Sohyun S Kang Sung Il SI

Trials 20200106 1

<h4>Background</h4>Although the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of negative-pressure wound therapy (NPWT) can reduce the healing period for many types of wounds. Herein, we describe a planned trial to test the hypothesis that NPWT can reduce the healing period for PSC after stoma reversal.<h4>Methods/design</h4>Patients undergoing stoma rev ...[more]

PMID: 31907033

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Project description:ImportanceNegative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI).ObjectiveTo evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice.Design, setting, and participantsThe multicenter, multinational, observer-blinded, randomized clinical SAWHI study enrolled patients between August 2, 2011, and January 31, 2018. The last follow-up date was June 11, 2018. The trial included 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence were randomly assigned to the treatment arms in a 1:1 ratio stratified by study site and wound size using a centralized web-based tool. A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population.InterventionsNegative pressure wound therapy and conventional wound treatment (CWT).Main outcomes and measuresThe primary outcome was time until wound closure (delayed primary closure or by secondary intention) within 42 days. Safety analysis comprised the adverse events (AEs). Secondary outcomes included wound closure rate, quality of life (SF-36), pain, and patient satisfaction.ResultsOf the 507 study participants included in the modified ITT population, 287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4%) (NPWT, 101 [39.5%] and CWT 119 [47.4%]). The median (IQR) age of the participants was 66 (18) years in the NPWT arm and 66 (20) years in the CWT arm. Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days) (difference, 3.0 days; 95% CI 1.6-4.4; P < .001). Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%) (difference, 14.4%; 95% CI, 6.6%-22.2%; P < .001). In the therapy-compliant population, excluding study participants with unauthorized treatment changes (NPWT, 22; CWT, 50), the risk for wound-related AEs was higher in the NPWT arm (risk ratio, 1.51; 95% CI, 0.99-2.35).Conclusions and relevanceNegative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs.Trial registrationClinicalTrials.gov Identifier: NCT01528033.

Dataset Information

The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study).

Publications

The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study).

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