PREP-IT (closed fracture)
Trial question
What is the role of skin antisepsis with iodine povacrylex in alcohol in patients with closed fractures?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 6784
6784 patients (3469 female, 3315 male).
Inclusion criteria: patients with a closed lower limb or pelvic fracture undergoing surgical fixation.
Key exclusion criteria: concurrent open fracture; medical contraindication to receive either trial intervention; chronic or acute infection at or near the fracture site at the time of the index surgery.
Interventions
N=3360 iodine povacrylex (a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol).
N=3425 chlorhexidine gluconate (a solution of 2% chlorhexidine gluconate in 70% isopropyl alcohol).
Primary outcome
Surgical site infection
2.4%
3.3%
3.3 %
2.5 %
1.6 %
0.8 %
0.0 %
Iodine
povacrylex
Chlorhexidine
gluconate
Significant
decrease ▼
NNT = 111
Significant decrease in surgical site infection (2.4% vs. 3.3%; OR 0.74, 95% CI 0.55 to 1).
Secondary outcomes
No significant difference in unplanned reoperation (5.5% vs. 5.9%; OR 0.96, 96% CI 0.77 to 1.2).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with a closed lower limb or pelvic fracture undergoing surgical fixation, iodine povacrylex was 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.
Open reference URL