Randomized clinical study to compare negative pressure wound therapy with simultaneous saline irrigation and traditional negative pressure wound therapy for complex foot infections.

"Conflict of Interest : The authors do not have any relevant conflict of interest."

"Source of funding : This was an investigator‐initiated study funded by Cardinal Health, Inc., Dublin, OH, USA."

"This was a pilot study to obtain preliminary data to assess the efficacy of NPWT with simultaneous irrigation. We planned to use the data to identify the effect size of primary and secondary outcomes to develop a cogent sample size justification help and plan a larger clinical trial. We summarized study variables as means and standard deviations (SD) for continuous variables and proportions or percentages for categorical variables. We used ANOVA to test for differences in continuous variables. For categorical variables, we used chi‐square to compare the proportion of outcomes in each treatment arm with an alpha of 0.05, and we used Kaplan Meier analysis to compare closure rates of the three treatment groups. p‐values were reported using the step‐up Bonferroni method of Hochberg. We used an adjusted two‐sided analysis with an alpha of 0.05. In this intent to treat analysis, we used the last observation carried forward to define the clinical outcomes for patients that were lost to follow up. This study was approved by the UT Southwestern Institutional Review Board (IRB # 032015‐099) and registered with http://www.clinicaltrials.gov as NCT02519621."