Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Conditions
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Fractures, Open

Intervention / Treatment
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* Drug: Tobramycin
* Other: Placebo: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic<br>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. | Drug: Tobramycin<br> <br> |
| Placebo Comparator: Normal Saline<br>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. | Other: Placebo: normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Wound Infection | Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics | 6 weeks post op |