Evidence brief
Effect of a Gentamicin-Impregnated Nail Coating on Prevention of Deep Surgical Site Infection After Intramedullary Nailing
Gentamicin-coated nail did not significantly reduce deep surgical site infection
Deep SSI: 3.8% coated vs 3.1% uncoated (not significant)
1,018 patients with open tibial fractures randomized
Primary outcome at 6 months
Stopped early for futility
The INSITE trial challenged the assumption that antibiotic-coated implants would reduce infection in high-risk open fractures. Standard uncoated nails with systemic antibiotics remain the standard of care.
When discussing infection prevention in open fractures, know that INSITE showed no benefit of gentamicin-coated nails. Standard care (debridement, systemic antibiotics, timely stabilization) remains key.
Level I
Systematic review of RCTs or high-quality RCT