Injury - 2026-04-01 - Journal Article
Local use of antibiotic-impregnated calcium sulfate for infection prophylaxis: A novel study.
Gómez-Masdeu M, De Caso Rodríguez J, Billi AM, Zuriarrain SW, Gelber PE, Fernández IC
Topics
Key Takeaway
Vancomycin-gentamicin calcium sulfate (Stimulan) did not reduce FRI rates in tibial plateau fracture fixation (18.9% vs 18.2%, p=0.896), while Schatzker IV–VI pattern was the dominant risk factor (27.9% vs 6.9%, p<0.001).
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Summary
This study asked whether intraoperative local vancomycin-gentamicin calcium sulfate (Stimulan) reduces FRI after surgical TPF fixation compared to no local antibiotic. In 209 patients (75 antibiotic, 134 control) at a single major trauma centre, FRI by FRI Consensus Group Criteria occurred in 18.9% vs 18.2% (p=0.896). Multivariate analysis identified high-energy fracture pattern (Schatzker IV–VI) as the primary independent predictor of FRI (27.9% vs 6.9%, p<0.001); diabetes trended toward significance (p=0.051) but did not reach it.
Key Limitation
Retrospective non-randomized design with unequal group sizes and no standardization of systemic antibiotic prophylaxis protocols across the 13-year study period limits causal inference.
Original Abstract
BACKGROUND
Fracture-related infection (FRI) remains a major complication after Tibial Plateau Fracture (TPF) fixation, particularly in high-energy injuries. The efficacy of locally applied antibiotic-impregnated calcium sulfate as infection prophylaxis is unclear.
METHODS
A retrospective study was conducted on 209 adult patients treated surgically for TPF from March 2010 to December 2023 at a major trauma centre. The exclusion criteria were defined as: patients under the age of 18, open fractures, compartment syndrome, pathological fractures and conservative treatment. Patients were administered either vancomycin-gentamycin impregnated calcium sulfate (Stimulan ®; n = 75) or no local antibiotic (n = 134) during fracture fixation. Infection rates (FRI Consensus Group Criteria), demographics and fracture characteristics were compared. Univariate and multivariate logistic analysis models were used to investigate the potential risk factors.
RESULTS
Mean follow-up period was 21 months. FRI occurred in 18.9 % of the antibiotic group and 18.2 % of non-antibiotic group (p = 0.896). A statistically significant difference for FRI was identified between high-energy fractures (Schatzker IV-VI) and low-energy fractures (27.9 % vs 6.9 %; p < 0.001). Diabetes showed a trend toward increased FRI (p = 0.051) but was not independently significant. No calcium sulfate related complications were observed.
CONCLUSION
Local use of vancomycin and gentamycin loaded calcium sulfate in TPF fixation did not significantly reduce postoperative infection rates. High-energy fractures have been identified as the primary predictor for FRI. Further prospective studies are required to delineate the role of local antibiotic bone substitutes for infection prophylaxis after TPF fixation.