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Gentamicin Open Tibia Study

RecruitingPhase 4

Sponsor: University of California, San Francisco

Conditions: Fracture Open Tibia

Interventions: Gentamicin, normal Saline

Countries: Tanzania

Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This study aims 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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age\>18 years old
* Open tibial shaft fracture meeting the following criteria:

  1. Orthopaed Trauma Association (OTA) Type 42
  2. Primarily closable wound
  3. Gustilo-Anderson (GA) Type I, II, or IIIA

Exclusion Criteria:

* Time from injury to presentation \> 48 hours
* Time from injury to surgery \> 7 days
* Aminoglycoside allergy
* GA IIIB or IIIC open fractures
* Bilateral open tibial fractures
* Severe brain (GCS\<12) or spinal cord injury
* Severe vascular injury
* Severe burns (\>10% Total Body Surface Area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
* Pathologic fracture
* History of active limb infection, ipsilaterally
* Unlikely to complete follow-up

Locations (1)

Dar es Salaam, Tanzania