Gentamicin Open Tibia Study

NCT ID: NCT05157126

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 890 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2029-04-30

Brief Summary

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.

Detailed 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.

Conditions

Fracture Open Tibia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Gentamicin

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.

Group Type: EXPERIMENTAL

Gentamicin

Intervention Type: DRUG

Liquid gentamicin administered at the open fracture site

Saline

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.

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

Normal saline administered at the open fracture site

Interventions

Gentamicin

Liquid gentamicin administered at the open fracture site

Intervention Type: DRUG

normal Saline

Normal saline administered at the open fracture site

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhimbili Orthopaedic Institute

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Orthopedic Research and Education Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W Shearer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Billy T Haonga, MD

Role: PRINCIPAL_INVESTIGATOR

Muhimbili Orthopaedic Institute

Locations

Muhimbili Orthopaedic Institute

Dar es Salaam, , Tanzania

Site Status: RECRUITING

Countries

Tanzania

Central Contacts

David W Shearer, MD, MPH

Role: CONTACT

david.shearer@ucsf.edu

628-206-8812

Tigist Belaye, MPA

Role: CONTACT

tigist.belaye@ucsf.edu

628-206-8812

Facility Contacts

Billy T Haonga, MD

Role: primary

255-022-2151298

References

Haonga BT, O'Marr JM, Ngunyale P, Ngahyoma J, Kessey J, Sasillo I, Rodarte P, Belaye T, Berhaneselase E, Eliezer E, Porco TC, Morshed S, Shearer DW. GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures. Trials. 2023 Jun 15;24(1):406. doi: 10.1186/s13063-023-07410-0.

Reference Type: DERIVED

PMID: 37322521 (View on PubMed)

Other Identifiers

K23AR079044

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-35369

Identifier Type: -

Identifier Source: org_study_id