Dörthe Seidel 1, Stephan Diedrich 2, Florian Herrle 3, Henryk Thielemann 4, Frank Marusch 5, Rebekka Schirren 6, Recca Talaulicar 7, Tobias Gehrig 8, Nadja Lehwald-Tywuschik 9, Matthias Glanemann 10, Jörg Bunse 11, Martin Hüttemann 12, Chris Braumann 13, Oleg Heizmann 14, Marc Miserez 15, Thomas Krönert 16, Stephan Gretschel 17, Rolf Lefering 1
Main idea: Negative pressure wound therapy is an effective treatment option for subcutaneous abdominal wound healing impairment after surgery; however, it causes more wound-related adverse events.
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 trial included 34 abdominal surgical departments in Germany, Belgium, and the Netherlands. 539 consecutive, compliant adult patients with SAWhi after surgery without fascia dehiscence were randomly assigned to the treatment arms. A total of 507 study participants were assessed for the primary endpoint 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%) and 220 were women (43.4%) In the therapy-compliant population, excluding study participants with unauthorized treatment changes, the risk for wound-related AEs was higher in the NPWT arm. Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%)