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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2022-01-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

\[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.\]

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

intravenous (IV) prophylactic antibiotic

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

topical irrigation with sterile normal saline (NS)

Intervention Type DRUG

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

intravenous (IV) prophylactic antibiotic

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

topical irrigation with sterile normal saline (NS)

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

Intervention Type DRUG

intravenous (IV) prophylactic antibiotic

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

Intervention Type DRUG

Eligibility Criteria

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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