MedTrace Logo

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

NCT03483363 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-05-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Surgical Site Infection

Interventions

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.

DRUG

topical irrigation with sterile normal saline (NS)

Fractures will be irrigated with sterile normal saline prior to closure.

DRUG

intravenous (IV) prophylactic antibiotic

All arms with receive standard parenteral (IV) prophylactic antibiotic.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Nagi Demian, MDDS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2022-01-02
Completion
2022-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483363 on ClinicalTrials.gov