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Table 1 Baseline characteristics and fracture management

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

 

Povidone-Iodine

Chlorhexidine

Participant characteristics

(n = XXX)

(n = XXX)

 Age, years, mean (SD)

  

 Sex, n (%)

  

  Male

  

 Body mass index, kg/m2, n (%)

  

  Underweight (BMI < 18.5)

  

  Normal weight (18.5–24.9)

  

  Overweight (25–29.9)

  

  Obese (BMI > 30)

  

 Diabetes, n (%)

  

 Current smoker, n (%)

  

 Injury severity score, median (IQR)

  

 American Society of Anesthesiologists Physical Score, n (%)

  

  Class I or II

  

  Class III or higher

  

Fracture characteristics

(n = XXX)

(n = XXX)

 Severity of open fracture, n (%)

  

  Gustilo-Anderson type I/II

  

  Gustilo-Anderson type IIIA

  

  Gustilo-Anderson type IIIB/IIC

  

 Location of fracture, n (%)

  

  Lower extremity or pelvis

  

  Upper extremity

  

 Wound contamination, n (%)

  

  None or minimal contamination

  

  Surface contamination

  

  Contaminant embedded in bone or deep soft tissue

  

Fracture management

(n = XXX)

(n = XXX)

 Temporary fracture stabilization, n (%)

  

 Number of planned surgeries, n (%)

  

  1

  

  2

  

  3 or more

  

 Preoperative antiseptic bathing with chlorhexidine gluconate*, n (%)

  

 Method of definitive fracture management, n (%)

  

  Plate and screw fixation

  

  Intramedullary nail

  

  External fixation

  

  Other

  

 Intraoperative topical antibiotics*, n (%)

  

 Skin closure method**, n (%)

  

  Primary wound closure

  

  Skin graft

  

  Local flap

  

  Free flap

  

  No closure attempted/secondary wound healing

  
  1. Fracture data includes all eligible participant injuries
  2. *Intervention reported for the definitive fracture management surgery only
  3. **Only the most complex wound closure method is reported if multiple methods were used