PREP-IT (open fracture)
Trial question
What is the role of skin antisepsis with iodine povacrylex in alcohol in patients with open fractures?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 1700
1700 patients (621 female, 1079 male)
Inclusion criteria: patients with an open upper limb or lower limb fracture warranting surgical fixation
Key exclusion criteria: open fractures of the hand and those who had received previous surgical debridement at a nonparticipating hospital
Interventions
N=854 iodine povacrylex (a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol)
N=846 chlorhexidine gluconate (a solution of 2% chlorhexidine gluconate in 70% isopropyl alcohol)
Primary outcome
Surgical site infection
6.5
7.3
7.3 %
5.5 %
3.6 %
1.8 %
0.0 %
Iodine
povacrylex
Chlorhexidine
gluconate
No significant
difference ↔
No significant difference in surgical site infection (6.5% vs. 7.3%; OR 0.86, 95% CI 0.58 to 1.27)
Secondary outcomes
No significant difference in unplanned reoperation (16.1% vs. 14.5%; OR 1.16, 95% CI 0.87 to 1.54)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with an open upper limb or lower limb fracture warranting surgical fixation, iodine povacrylex was not superior to chlorhexidine gluconate with respect to surgical site infection.
Reference
PREP-IT Investigators, Sheila Sprague, Gerard Slobogean et al. Skin Antisepsis before Surgical Fixation of Extremity Fractures. N Engl J Med. 2024 Feb 1;390(5):409-420.
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