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Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

ABSTRACT: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated.The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms.The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

SUBMITTER: Seidel D

PROVIDER: S-EPMC4225503 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

Seidel Dörthe D Lefering Rolf R Neugebauer Edmund A M EA

Trials 20131120

<h4>Background</h4>A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative ...[more]

PMID: 24252551

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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.

Project description:Introduction: Several different temporary abdominal closure techniques are described in the context of open abdomen treatment. Techniques based on dynamic fascial closure combined with negative pressure therapy have gained popularity and seem to result in the highest fascial closure rates without increased complications and are highlighted in recent guidelines and recommendations. One dynamic closure technique is the vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) technique, first described in 2007. The aim of this systematic review was to evaluate the VAWCM technique regarding a number of short- and long-term results. Materials and Methods: A systematic literature search was performed in PubMed, EMBASE, and Cochrane Library databases for articles published between January 1, 2006 and May 8, 2020. The review was independently performed by the two authors according to the PRISMA statements for reporting systematic reviews and meta-analyses. Results were pooled for presentation of weighted means when applicable. Results: A total of 220 articles were screened by title and abstract. Thirty-two articles were assessed for eligibility by full-text review and 15 articles finally remained for review. A total of 600 patients treated with VAWCM were included. The pooled weighted means were as follows: fascial closure, 83.5%; enteroatmospheric fistula, 5.6%; planned ventral hernia, 6.2%; in-hospital survival, 72%; and incisional hernia incidence, 40.5%. Long-term survival ranged between 22 and 72%. Quality of life (SF-36) was reported in two studies showing lower scores than the population mean especially in physical domains. Incisional hernia resulted in lower scores in one but not in the other study. Discussion: The results of 600 VAWCM-treated patients from 15 studies were evaluated in this systematic review. Earlier findings with high fascial closure rates, low enteroatmospheric fistula, and planned ventral hernia rates as well as high incisional hernia incidences were underlined. Permanent mesh for efficient fascial traction and reinforcement at fascial closure seem to be the next step in evolving an optimal temporary closure technique in open abdomen treatment.

Project description:Randomised clinical trials (RCTs) to evaluate diabetic foot wound therapies have systematically eliminated large acute wounds from evaluation, focusing only on smaller chronic wounds. The purpose of this study was to evaluate the proportion and rate of wound healing in acute and chronic wounds after partial foot amputation in individuals with diabetes treated with negative pressure wound therapy (NPWT) delivered by the vacuum-assisted closure (VAC) device or with standard wound therapy (SWT). This study constitutes a secondary analysis of patients enrolled in a 16-week RCT of NPWT: 162 open foot amputation wounds (mean wound size = 20.7 cm(2)) were included. Acute wounds were defined as the wounds less than 30 days after amputation, whereas chronic wounds as the wounds greater than 30 days. Inclusion criteria consisted of individuals older than 18 years, presence of a diabetic foot amputation wound up to the transmetatarsal level and adequate perfusion. Wound size and healing were confirmed by independent, blinded wound evaluators. Analyses were done on an intent-to-treat basis. There was a significantly higher proportion of acute wounds (SWT = 59; NPWT = 63) than chronic wounds (SWT = 26; NPWT = 14), evaluated in this clinical trial (P = 0.001). There was no significant difference in the proportion of acute and chronic wounds achieving complete wound closure in either treatment group. Despite this finding, the Kaplan-Meier curves demonstrated statistically significantly faster healing in the NPWT group in both acute (P = 0.030) and chronic wounds (P = 0.033). Among the patients treated with NPWT via the VAC, there was not a significant difference in healing as a function of chronicity. In both the acute and the chronic wound groups, results for patients treated with NPWT were superior to those for the patients treated with SWT. These results appear to indicate that wound duration should not deter the clinician from using this modality to treat complex wounds.

Dataset Information

Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

Publications

Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

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