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NCT03483363 Clinical Trial

Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds

Surgical Site Infection Clinical Trial

Official title:
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03483363
Other study ID # HSC-DB-18-0038
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date October 9, 2018
Est. completion date January 2, 2022

Study information
Verified date April 2024
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.

Recruitment information / eligibility
Status Terminated
Enrollment 39
Est. completion date January 2, 2022
Est. primary completion date January 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care - patients who are admitted to Memorial Hermann hospital at Texas Medical Center - able to sign their own consent Exclusion Criteria: - infected surgical sites - allergies to bacitracin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)
Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
• topical irrigation with sterile normal saline (NS)
Fractures will be irrigated with sterile normal saline prior to closure.
• intravenous (IV) prophylactic antibiotic
All arms with receive standard parenteral (IV) prophylactic antibiotic.

Locations
Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Surgical Site Infection (SSI) Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge. 8 weeks
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