Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania (pGO-Tibia)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Open Tibia Fracture

Treatments: Drug: placebo saline injection; Drug: local gentamicin injection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03559400

17-23950

K23AR079044 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

Full description

This pilot study is being conducted in Dar es Salaam, Tanzania to assess the feasibility of a masked, placebo-controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. The study will enroll patients within 1 week of injury. The active or placebo agent will be administered during the initial surgical debridement based on a web-based randomization tool. Patients will be followed for 1 year after surgery to assess for the occurrence of fracture-related infection (FRI), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. Additional clinical and economic endpoints will also be measured.

Depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent FRI. If proven effective, local gentamicin would impact the clinical care of open fracture patients both in Tanzania and likely in high-income settings as well. These data will also deepen the understanding of the clinical and economic impact of FRI in open fracture populations.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female patients age 18 or older

2. Diagnosis of an acute open tibial shaft fracture meeting the following criteria:

   1. AO/OTA Type 42
   2. Primarily closable wound
   3. Type I, II, or IIIA Gustilo- Anderson (GA) Classification

Exclusion criteria

1. Time from injury to presentation > 48 hours
2. Time from injury to surgery >7 days
3. History of Aminoglycoside allergy
4. GA IIIB or IIIC open fractures
5. Bilateral open tibial fractures
6. Severe brain (GCS<12) or spinal cord injury
7. Severe vascular injury
8. Sustained severe burns (>10% total body surface area (TBSA) or >5% TBSA with full thickness or circumferential injury)
9. Pathologic fracture
10. History of active limb infection, ipsilaterally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

gentamicin injection at fracture site

Experimental group

Description:

Subjects with an open tibia fracture who receive gentamicin in saline solution administered after closure at the time of initial debridement.

Treatment:

Drug: local gentamicin injection

placebo saline injection at fracture site

Placebo Comparator group

Description:

Subjects with an open tibia fracture who receive placebo saline solution administered after closure at the time of initial debridement.

Treatment:

Drug: placebo saline injection