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ABSTRACT: Background
Surgical site infection (SSI) is one of the leading complications in health care. Negative pressure wound therapy (NPWT) is meanwhile widely prophylactically used for preventing SSIs. For evaluating the results of the implantation of this technique, we used the Simon single-arm study design and examine whether NPWT has a prophylactic effect on reducing SSIs in a cohort of general surgery patients.Methods
This single-arm, two-stage study includes 81 elective general surgery patients and corresponds to the Simon's design. The sample size calculation was based on a reduction in the superficial SSI rate from 12 to 4% (power 80%, significance level 5%) using a NPWT system. In compliance with Simon's two-Stage design, the study required the recruitment of 34 patients i
SUBMITTER: Piroski V
PROVIDER: S-EPMC9421711 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature