Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

NCT ID: NCT03705962

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-03-07

Brief Summary

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.

Conditions

Fractures, Open

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antibiotic

Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.

Group Type: EXPERIMENTAL

Tobramycin

Intervention Type: DRUG

Normal Saline

Subjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.

Group Type: PLACEBO_COMPARATOR

Placebo: normal saline

Intervention Type: OTHER

Interventions

Tobramycin

Intervention Type: DRUG

Placebo: normal saline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 18 - 70 years
• Gustilo Type I,II,IIIa open fracture (s)
• Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
• Subject should be able to follow up at the scheduled times following surgery
• Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study

Exclusion Criteria

• Closed fracture
• Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
• Aminoglycoside allergy
• Presentation greater than 48 hours after injury
• Pathologic fracture
• Preexisting infection in bone with an open fracture
• Patients with multiple trauma involving liver, kidney, or brain
• Pregnancy (self-reported)
• Current status as prisoner

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Seth Yarboro, MD

Assistant Professor Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Yarboro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Medical Center

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

18088

Identifier Type: -

Identifier Source: org_study_id