PMID- 32293657 OWN - NLM STAT- MEDLINE DCOM- 20210222 LR - 20210222 IS - 2168-6262 (Electronic) IS - 2168-6254 (Print) IS - 2168-6254 (Linking) VI - 155 IP - 6 DP - 2020 Jun 1 TI - Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. PG - 469-478 LID - 10.1001/jamasurg.2020.0414 [doi] AB - IMPORTANCE: Negative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI). OBJECTIVE: To evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice. DESIGN, SETTING, AND PARTICIPANTS: The 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. INTERVENTIONS: Negative pressure wound therapy and conventional wound treatment (CWT). MAIN OUTCOMES AND MEASURES: The 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. RESULTS: Of 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 RELEVANCE: Negative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01528033. FAU - Seidel, Dorthe AU - Seidel D AD - Institute for Research in Operative Medicine, University of Witten/Herdecke, Cologne, Germany. FAU - Diedrich, Stephan AU - Diedrich S AD - Department of General Surgery, Visceral, Thoracic and Vascular Surgery, Greifswald University Hospital, Greifswald, Germany. FAU - Herrle, Florian AU - Herrle F AD - Department of Surgery, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. FAU - Thielemann, Henryk AU - Thielemann H AD - Department of General and Abdominal Surgery, Unfallkrankenhaus Berlin, Berlin, Germany. FAU - Marusch, Frank AU - Marusch F AD - Department of General and Visceral Surgery, Klinikum Ernst von Bergmann gemeinnutzige GmbH, Potsdam, Germany. FAU - Schirren, Rebekka AU - Schirren R AD - Department and Polyclinic of Surgery, Hospital Rechts der Isar -Technical University of Munich, Munchen, Germany. FAU - Talaulicar, Recca AU - Talaulicar R AD - Department of General, Visceral and Pediatric Surgery, University Medical Center Gottingen, Gottingen, Germany. FAU - Gehrig, Tobias AU - Gehrig T AD - Department of General and Visceral Surgery, GRN Klinik Sinsheim, Sinsheim, Germany. FAU - Lehwald-Tywuschik, Nadja AU - Lehwald-Tywuschik N AD - Department of Surgery (A), Hospital of the Heinrich-Heine-University Dusseldorf, Dusseldorf, Germany. FAU - Glanemann, Matthias AU - Glanemann M AD - Department of General, Visceral, Vascular and Pediatric Surgery, Saarland University, Homburg, Germany. FAU - Bunse, Jorg AU - Bunse J AD - Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany. FAU - Huttemann, Martin AU - Huttemann M AD - Department of General and Visceral Surgery, Evangelisches Krankenhaus Oberhausen, Oberhausen, Germany. FAU - Braumann, Chris AU - Braumann C AD - Department of General and Visceral Surgery, St Josef-Hospital Bochum, Bochum, Germany. FAU - Heizmann, Oleg AU - Heizmann O AD - Department of General, Visceral und Thoracic Surgery, Agaplesion Diakonieklinikum Rotenburg gemeinnutzige GmbH, Rotenburg (Wumme), Germany. FAU - Miserez, Marc AU - Miserez M AD - Department of Abdominal Surgery, University Hospitals Katholieke Universiteit Leuven, Leuven, Belgium. FAU - Kronert, Thomas AU - Kronert T AD - Center for Vascular Medicine, Department of Vascular Surgery, Thuringen Kliniken Georgius Agricola, Saalfeld, Germany. FAU - Gretschel, Stephan AU - Gretschel S AD - Brandenburg Medical School,Department of General and Visceral Surgery, University Hospital Neuruppin, Neuruppin, Germany. FAU - Lefering, Rolf AU - Lefering R AD - Institute for Research in Operative Medicine, University of Witten/Herdecke, Cologne, Germany. LA - eng SI - ClinicalTrials.gov/NCT01528033 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - JAMA Surg JT - JAMA surgery JID - 101589553 SB - IM CIN - JAMA Surg. 2020 Jun 1;155(6):479. PMID: 32293660 MH - *Abdominal Wound Closure Techniques MH - Adult MH - Aged MH - Aged, 80 and over MH - Belgium MH - Female MH - Germany MH - Humans MH - Male MH - Middle Aged MH - *Negative-Pressure Wound Therapy/adverse effects MH - Netherlands MH - Subcutaneous Tissue/surgery MH - Treatment Outcome MH - Wound Healing PMC - PMC7160755 COIS- Conflict of Interest Disclosures: Ms Seidel reported grants from Kinetic Concepts Incorporated (KCI), an Acelity company, during the conduct of the study; other support from Smith & Nephew Honoraria for lectures, grants from Smith & Nephew, KCI, and from German statutory health insurance funds (AOK-Bundesverband, Verband der Ersatzkrankenkassen (vdek), Knappschaft) outside the submitted work. Drs Diedrich, Herrle, Thielmann, Marusch, Schirren, Talaulicar, Gehrig, Tyquschik, Glanemann, Bunse, Huttemann, Heizmann Miserez, Gretschel, Lefering, reported grants from the Institute for Research in Operative Medicine (Witten/Herdecke University) and received compensation for traveling to investigator meetings during the conduct of the study. Prof Marusch reported personal fees from Coloplast Lectures outside the submitted work. Dr Schirren reported other support from KCI (an Acelity company) outside the submitted work. Dr Bunse reported other financial support from Acelity outside the submitted work; and membership in the German Wound Healing Society. Dr Braumann reported personal fees from KCI (an Acelity company) outside the submitted work. Dr Kroenert reported grants from Institute for Research in Operative Medicine (Witten/Herdecke University) during the conduct of the study. Dr Lefering reported grants from KCI (an Acelity company) and grants from Smith & Nephew and German statutory health insurance funds (AOK-Bundesverband, Verband der Ersatzkassen [vdek]) outside the submitted work. EDAT- 2020/04/16 06:00 MHDA- 2021/02/23 06:00 PMCR- 2020/04/15 CRDT- 2020/04/16 06:00 PHST- 2020/04/16 06:00 [pubmed] PHST- 2021/02/23 06:00 [medline] PHST- 2020/04/16 06:00 [entrez] PHST- 2020/04/15 00:00 [pmc-release] AID - 2763979 [pii] AID - soi200011 [pii] AID - 10.1001/jamasurg.2020.0414 [doi] PST - ppublish SO - JAMA Surg. 2020 Jun 1;155(6):469-478. doi: 10.1001/jamasurg.2020.0414.