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

NCT03483363 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HSC-DB-18-0038
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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); Drug: intravenous (IV) prophylactic antibiotic

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

ACTIVE COMPARATOR

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); Drug: intravenous (IV) prophylactic antibiotic

Interventions

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

Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.

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

topical irrigation with sterile normal saline (NS) DRUG

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

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

intravenous (IV) prophylactic antibiotic DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• infected surgical sites
• allergies to bacitracin

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Therapeutic Irrigation; Gentamicins; Saline Solution; Chemoprevention

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Aminoglycosides; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Therapy

Results Point of Contact

• Title: Nagi Demian, MDDS
• Organization: The University of Texas Health Science Center at Houston

Nagi.Demian@uth.tmc.edu

(713) 500-5082

Study Officials

• Nagi Demian, MDDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: October 9, 2018
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2024-04

Locations

US (1)