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. 2023 Mar 27;6(2):e268.
doi: 10.1097/OI9.0000000000000268. eCollection 2023 Jun.

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia)

Billy T Haonga  1 , Patrick Ngunyale  1 , Ericka P von Kaeppler  2 , Claire A Donnelley  2 , Nae Y Won  2 , Edmund N Eliezer  1 , Kelsey Brown  2 , Michael Flores  2 , Jamieson M O'Marr  2 , Patricia Rodarte  2 , Mayur Urva  2 , Abigail Cortez  2 , Travis Porco  3 , Saam Morshed  2 , David W Shearer  2
Affiliations

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia)

Billy T Haonga et al. OTA Int. .

Abstract

Background: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.

Methods: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection.

Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes.

Conclusion: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting.

Keywords: fracture related infection; local antibiotics; open tibia fracture.

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Conflict of interest statement

The authors have no conflicts of interest to disclose

Figures

Figure 1.
Figure 1.
Consort flow diagram for the pGO-Tibia study.
Figure 2.
Figure 2.
Change in serum creatinine by treatment group. The dashed red line represents a 25 umol/L rise in serum creatine, which was defined as an AKI in our study. AKI, acute kidney injury.
Figure 3.
Figure 3.
EuroQol 5 Dimensions (EQ-5D) index over time by treatment group. The mean EQ-5D score plotted over time at each follow-up time point. The saline group is represented by the blue dots while the gentamicin group is represented by the red dots.
Figure 4.
Figure 4.
Modified Radiographic Union Scale for Tibia (mRUST) by treatment group. The mean mRUST score plotted over time at each follow-up time point. The saline group is represented by the blue dots while the gentamicin group is represented by the red dots.
Figure 5.
Figure 5.
Functional IndeX for intermedullary nailed tibial fractures (FIX-IT) score by treatment group. The mean FIX-IT score plotted over time at each follow-up time point. The saline group is represented by the blue dots while the gentamicin group is represented by the red dots.
See this image and copyright information in PMC

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