Trial Outcomes & Findings for Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds (NCT NCT03483363)
NCT ID: NCT03483363
Last Updated: 2024-05-08
Results Overview
Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
22
|
|
Overall Study
COMPLETED
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic
n=17 Participants
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.
|
Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic
n=22 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.82 years
STANDARD_DEVIATION 15.06 • n=17 Participants
|
37.81 years
STANDARD_DEVIATION 15.18 • n=22 Participants
|
41.30 years
STANDARD_DEVIATION 15.46 • n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=17 Participants
|
6 Participants
n=22 Participants
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=17 Participants
|
16 Participants
n=22 Participants
|
29 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
22 participants
n=22 Participants
|
39 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 8 weeksSurgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Outcome measures
| Measure |
Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic
n=17 Participants
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.
|
Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic
n=22 Participants
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.
|
|---|---|---|
|
Number of Participants With Surgical Site Infection (SSI)
|
0 Participants
|
0 Participants
|
Adverse Events
Topical Irrigation With the Antibiotic Plus Intravenous (IV) Prophylactic Antibiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Irrigation With Sterile Normal Saline (NS) Plus Intravenous (IV) Prophylactic Antibiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nagi Demian, MDDS
The University of Texas Health Science Center at Houston
Phone: (713) 500-5082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place