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

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Surgical Site Infection

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT03483363

HSC-DB-18-0038

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

39 participants in 2 patient groups

topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic

Experimental group

Description:

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

Treatment:

Drug: intravenous (IV) prophylactic antibiotic

Drug: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)

topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic

Active Comparator group

Description:

Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.

Treatment:

Drug: intravenous (IV) prophylactic antibiotic

Drug: topical irrigation with sterile normal saline (NS)