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. 2024 Jan 1;38(1):10-17.
doi: 10.1097/BOT.0000000000002704.

The VANCO Trial Findings Are Generalizable to a North American Trauma Registry

Joseph T Patterson  1 , Gerard P Slobogean  2 , Joshua L Gary  1 , Renan C Castillo  3 , Reza Firoozabadi  4 , Anthony R Carlini  3 , Manjari Joshi  5 , Lauren E Allen  3 , Yanjie Huang  6 , Michael J Bosse  7 , William T Obremskey  8 , Todd O McKinley  9 , J Spence Reid  10 , Robert V O'Toole  2 , Nathan N O'Hara  2 ; and METRC
Affiliations

The VANCO Trial Findings Are Generalizable to a North American Trauma Registry

Joseph T Patterson et al. J Orthop Trauma. .

Abstract

Objectives: To estimate the generalizability of treatment effects observed in the VANCO trial to a broader population of patients with tibial plateau or pilon fractures.

Methods: Design and Setting: Clinical trial data from 36 United States trauma centers and Trauma Quality Programs registry data from more than 875 Level I-III trauma centers in the United States and Canada.Patient Selection Criteria: Patients enrolled in the VANCO trial treated with intrawound vancomycin powder from January 2015 to June 2017 and 31,924 VANCO-eligible TQP patients admitted in 2019 with tibial plateau and pilon fractures.Outcome Measure and Comparisons: Deep surgical site infection and gram-positive deep surgical site infection estimated in the TQP sample weighed by the inverse probability of trial participation.

Results: The 980 patients in the VANCO trial were highly representative of 31,924 TQP VANCO-eligible patients (Tipton generalizability index 0.96). It was estimated that intrawound vancomycin powder reduced the odds of deep surgical infection by odds ratio (OR) = 0.46 (95% confidence interval [CI] 0.25-0.86) and gram-positive deep surgical infection by OR = 0.39 (95% CI, 0.18-0.84) within the TQP sample of VANCO-eligible patients. For reference, the trial average treatment effects for deep surgical infection and gram-positive deep surgical infection were OR = 0.60 (95% CI, 0.37-0.98) and OR = 0.44 (95% CI, 0.23-0.80), respectively.

Conclusions: This generalizability analysis found that the inferences of the VANCO trial generalize and might even underestimate the effects of intrawound vancomycin powder when observed in a wider population of patients with tibial plateau and pilon fractures.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

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References

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