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Table 2 Study outcomes

From: A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan

 

Povidone-iodine (n = XXX)

Chlorhexidine (n = XXX)

Odds ratio (95% CI)

ARR (95% CI)

p value

Primary outcome

 Surgical site infection

     

 Superficial infection by 30 days

    

 Deep incisional by 90 days

    

 Organ/space infection by 90 days

    

Alternative definitions of SSI

 Any surgical site infection by 365 days

     

 Fracture-related infection by 365 days

     

Secondary outcome

 Unplanned reoperation by 365 days

     

 Unplanned reoperation for infection by 365 days

    

 Unplanned reoperation for wound healing complications by 365 days

    

 Unplanned reoperation to promote fracture healing by 365 days