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
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection

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