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Fracture Open TibiaPhase 4GO-TibiaNCT05157126

Gentamicin Open Tibia Study

A Phase 4 study testing Gentamicin and normal Saline in people with Fracture Open Tibia, run by University of California, San Francisco at 1 site in Tanzania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fracture Open Tibia
What is being tested?
Gentamicin and normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
890 participants
Where
1 siteTanzania
Study dates
1 Sep 2022to Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age>18 years old
  • Open tibial shaft fracture meeting the following criteria:
  • Orthopaed Trauma Association (OTA) Type 42
  • Primarily closable wound
  • Gustilo-Anderson (GA) Type I, II, or IIIA

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David W Shearer, MD, MPH contact

628-206-8812

david.shearer@ucsf.edu

Tigist Belaye, MPA contact

628-206-8812

tigist.belaye@ucsf.edu

Tanzania1 site, 1 recruiting

  • Muhimbili Orthopaedic Institute

    Dar es Salaam

    Billy T Haonga, MD, 255-022-2151298

    Billy T Haonga, MD

    Recruiting

Other trials in Tanzania

About this study

Official title: A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures

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.

Read the 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.

Being tested
Gentamicin, normal Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GentamicinDrug

    Liquid gentamicin administered at the open fracture site

  • normal SalineDrug

    Normal saline administered at the open fracture site

Study groups in NCT05157126
Study groupRoleWhat they receive
GentamicinExperimentalThe 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.
Receives: Drug: Gentamicin
SalinePlacebo comparatorThe 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.
Receives: Drug: normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of fracture-related infection (FRI)

    Fracture-related infection is a consensus definition of infection after fracture treatment. It is diagnosed by an orthopaedic surgeon based on any of the following four diagnostic criteria: (1) fistula, sinus or wound breakdown; (2) purulent drainage from the wound or presence of pus during surgery; (3) phenotypically indistinguishable pathogens identified by culture from at least two separate deep tissue/implant specimens; or (4) presence of microorganisms in deep tissue taken during an operative intervention, as seen on histopathological examination.

    FRI diagnosis is likely to peak between 6 weeks and 6 months after surgery and has a non-normal time-to-event distribution, with incident cases rarely presenting later than 12 months after surgery. All events will be confirmed by an independent adjudication committee comprised of three masked, non-treating orthopaedic trauma surgeons.

    Measured: 12 months

Secondary outcomes (6)

  1. Occurrence of nonunion

    Binary outcome based on the following criteria:

    1. Any unplanned reoperation for promotion of bone healing; OR
    2. Modified Radiographic Union Scale for Tibia Fractures (mRUST) ≤10 at 12 months follow-up AND either: Function IndeX for Trauma (FIX-IT) score ≤11 at 12 month follow-up, OR recommendation by treating surgeon for nonunion repair surgery

    Measured: 12 months

  2. Occurrence of unplanned fracture-related reoperation

    Occurrence of unplanned fracture-related reoperation, a binary variable, for infection, wound healing, or fracture union, excluding removal of implants for prominence/irritation. This may include but is not limited to:

    1. Irrigation and debridement of surgical incisions or open fracture wounds due to infections or wound healing problems;
    2. Revision wound closure for dehiscence;
    3. Soft tissue coverage procedure for infected or necrotic wound;
    4. Fracture delayed union or nonunion surgery (such as bone grafting or implant exchange);
    5. Reoperation for hardware or prosthesis failure due to infection or bone-healing problems;
    6. Amputation for infection, wound or fracture healing problem.

    Measured: 12 months

  3. Health-related quality-of-life (HRQOL) as measured by EQ-5D-3L (Swahili version)

    The EQ-5D is a survey instrument that assesses multiple domains of quality-of-life, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: 12 months

  4. Fracture healing by modified Radiographic Union Scale for Tibial fractures (mRUST score)

    The mRUST score is based on evaluation plain radiographs of the fracture site. Each cortex is scored from 1-4 based on the degree of healing and summed resulting in an ordinal scale ranging from 4 to 16, with higher score indicating greater fracture healing.

    Measured: 12 months

  5. Clinical fracture healing by Function IndeX for Trauma (FIX-IT)

    The FIX-IT score is an ordinal scale from 0-12 that encompasses two domains: ability to weight-bear and pain at fracture site, each scored from 0-6. Higher score indicates more clinical healing.

    Measured: 12 months

  6. Occurence of FRI Suggestive Criteria

    Suggestive criteria are signs/symptoms of infection that do not meet criteria for definitive fracture-related infection (FRI). These include clinical signs (wound redness, fever) and radiographic signs (sequestrum), elevated serum inflammatory markers, and new onset or increased non-purulent wound drainage.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start1 Sep 2022
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center individually-randomized placebo-controlled superiority trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
890 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157126
Sponsor's protocol ID
21-35369
Other IDs
K23AR079044
Acronym
GO-Tibia
Status last verified
Sep 2026
First submitted
30 Nov 2021
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37322521

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gentamicin and normal Saline in people with Fracture Open Tibia, run by University of California, San Francisco at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David W Shearer, MD, MPH (628-206-8812, david.shearer@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of fracture-related infection (FRI) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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