Gentamicin Open Tibia Study (GO-Tibia)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Fracture Open Tibia

Treatments: Drug: Gentamicin; Drug: normal Saline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05157126

21-35369

K23AR079044 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Tibial shaft (shinbone) fractures are the most common major fracture of the lower leg and are frequently associated with a break in the skin known as an open fracture. Because the bone is exposed by the open wound, open tibial fractures are often complicated by infection and failure of bone healing, which can lead to long-lasting disability and in some cases amputation. Intravenous antibiotics administered early after injury are a well-established measure to prevent fracture-related infection (FRI), but their effectiveness is limited by poor blood flow at the fracture site and inability to achieve high local concentrations with systemic administration. Gentamicin applied locally within the open fracture wound is a promising adjunctive measure to reduce the risk of FRI after these injuries, but there are no high-quality clinical trials evaluating its use.

This will be the first randomized trial evaluating locally administered gentamicin to reduce infection in a fracture population. If efficacious, local gentamicin is likely to be a highly cost-effective preventive strategy for FRI and may ultimately be cost saving. Although these findings will originate from a low-income country, results may be generalizable to populations in both high and low-income countries and could therefore significantly reduce the global burden of open fractures.

Enrollment: 890 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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890 participants in 2 patient groups, including a placebo group

Gentamicin

Experimental group

Description:

The intervention consists of 80mg of liquid gentamicin diluted in 5 mL normal saline (16mg/mL). The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.

Treatment:

Drug: Gentamicin

Saline

Placebo Comparator group

Description:

The control consists of 5 mL normal saline injected immediately after wound closure at the open fracture site. The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.

Treatment:

Drug: normal Saline