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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03705962
Other study ID # 18088
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date July 2015
Est. completion date March 7, 2019

Study information

Verified date May 2023
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date March 7, 2019
Est. primary completion date March 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tobramycin

Other:
Placebo: normal saline


Locations

Country Name City State
United States University of Virginia Medical Center Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Not yet recruiting NCT05435261 - Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures