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

Phase 4

Terminated

Conditions: Surgical Site Infection

Interventions: Drug: topical irrigation with sterile normal saline (NS)
Drug: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)
Drug: intravenous (IV) prophylactic antibiotic

Registration Number: NCT03483363

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic	intravenous (IV) prophylactic antibiotic	Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. \[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.\]
topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic	topical irrigation with sterile normal saline (NS)	Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic	intravenous (IV) prophylactic antibiotic	Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic	topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)	Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. \[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.\]

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Infection (SSI)	8 weeks	Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.

Secondary Outcome Measures