Surgical Site Infection
Conditions
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.
Interventions
DRUGtopical 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.
DRUGtopical irrigation with sterile normal saline (NS)
Fractures will be irrigated with sterile normal saline prior to closure.
DRUGintravenous (IV) prophylactic antibiotic
All arms with receive standard parenteral (IV) prophylactic antibiotic.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infection (SSI) | 8 weeks | Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
\[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.\]
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.
intravenous (IV) prophylactic antibiotic: All arms with receive standard parenteral (IV) prophylactic antibiotic. | 17 |
| 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.
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. | 22 |
| Total | 39 |
Baseline characteristics
| Characteristic | Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic | Total | Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic |
|---|---|---|---|
| Age, Continuous | 37.81 years STANDARD_DEVIATION 15.18 | 41.30 years STANDARD_DEVIATION 15.46 | 45.82 years STANDARD_DEVIATION 15.06 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 22 participants | 39 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 22 |
| other Total, other adverse events | 0 / 17 | 0 / 22 |
| serious Total, serious adverse events | 0 / 17 | 0 / 22 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic | Number of Participants With Surgical Site Infection (SSI) | 0 Participants |
| Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic | Number of Participants With Surgical Site Infection (SSI) | 0 Participants |