Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

University of Virginia

Status and phase: Terminated; Phase 3

Conditions: Fractures, Open

Treatments: Other: Placebo: normal saline; Drug: Tobramycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03705962

18088

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Antibiotic

Experimental group

Description:

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.

Treatment:

Drug: Tobramycin

Normal Saline

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo: normal saline