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

Purpose

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.

Condition

  • Surgical Site Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
topical irrigation with the antibiotic plus 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.]
  • 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: intravenous (IV) prophylactic antibiotic
    All arms with receive standard parenteral (IV) prophylactic antibiotic.
Active Comparator
topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic 		Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
  • 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.

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact