Trial Outcomes & Findings for Acute Application of Antibiotic Powder in Open Fracture Wounds (NCT NCT04872400)
NCT ID: NCT04872400
Last Updated: 2026-03-06
Results Overview
The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Within 6 months of injury date
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
Control
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
|
Vancomycin
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
Tobramycin
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
8
|
|
Overall Study
COMPLETED
|
7
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Application of Antibiotic Powder in Open Fracture Wounds
Baseline characteristics by cohort
| Measure |
Control
n=7 Participants
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
|
Vancomycin
n=4 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
Tobramycin
n=7 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
|
Age, Continuous
|
46.71 Years
STANDARD_DEVIATION 18.01 • n=41 Participants
|
38.00 Years
STANDARD_DEVIATION 11.60 • n=35 Participants
|
46.14 Years
STANDARD_DEVIATION 11.27 • n=76 Participants
|
44.56 Years
STANDARD_DEVIATION 14.80 • n=565 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
6 Participants
n=565 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
12 Participants
n=565 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
13 Participants
n=565 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
4 Participants
n=565 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
6 Participants
n=565 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
11 Participants
n=565 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of injury dateThe percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
Outcome measures
| Measure |
Tobramycin
n=7 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
Control
n=7 Participants
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
|
Vancomycin
n=4 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
|---|---|---|---|
|
Incidence of Surgical Site Infection During the Post-operative Follow-up Period
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Within 1 year of injury dateUnderstand the changes that occur in nonunion after antibiotic powder treatment .
Outcome measures
| Measure |
Tobramycin
n=7 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
Control
n=7 Participants
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
|
Vancomycin
n=4 Participants
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
|
|---|---|---|---|
|
Presence of Fracture Nonunion
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tobramycin
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
Nicholas Alfonso, M.D., Principal Investigator
University of Colorado - Anschutz Medical Campus
Phone: 303-724-1055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place