Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Fractures, Open Clinical Trial

Official title:

Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03705962
• Other study ID #: 18088
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open

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