Session X1 - Tibia
Immediate versus Delayed Closure of Grade II and IIIA Tibial Fractures: A Prospective, Randomized, Multicenter Study
Purpose: The delayed closure of open fractures doctrine was developed by Trueta in 1938. Despite significant clinical advances in wound, fracture, and antimicrobial therapies over the past 65+ years, this doctrine persists relatively uncontested and poorly researched. Surgeons would argue that the wound associated with an open fracture (noncombat) may be as clean as it is going to be at the completion of the initial debridement process. The practice of delayed wound closure risks exposure to nosocomial colonization by resistant bacteria. This study was designed to assess the outcome of patients treated with either immediate or delayed wound closure.
Methods: A prospective, randomized trial was conducted at 30 US trauma centers. Patients (n=451) with grade II or IIIA tibial diaphyseal fractures were treated with a standardized debridement, antibiotic, and reamed locked intramedullary nail protocol. At the conclusion of the initial surgery, patients were assigned to an immediate or delayed closure cohort. Patients were followed to determine the rates of infection, wound complications, rehospitalizations, and time to union. 387 patients (197 immediate, 190 delayed) had a mean follow-up of 296 days.
Results: The demographics and smoking rates were similar for the groups. Clinical outcomes were not significantly different:17 immediate (8.6%) and 18 delayed (9.5%) developed infection (P=0.77); 61 immediate (31%) and 52 (27%) delayed patients developed delayed union/nonunion; and mean time to union was 177 versus 173 days. Wound problems were more common in the delayed cohort (9 split-thickness skin grafts, 2 flaps) than in the immediate (2 split-thickness skin grafts, 2 flaps); P=0.055.
Conclusions/Significance: Except for a trend to increased wound complications needing revision surgery in the delayed cohort, no clinical differences were found. The infection rates were similar and much lower than expected or previously reported for grade II and IIIA tibia fractures. Using these data for a power analysis, 5000 patients would be required to show a difference if infection is the primary outcome. A cost effectiveness study would require 700 patients. The delayed closure doctrine for open fracture may need to be revised. A cost effectiveness study appears to be an appropriate design to determine the efficacy of either immediate or delayed wound treatment.