Trial Outcomes & Findings for Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge (NCT NCT01222832)
NCT ID: NCT01222832
Last Updated: 2017-05-31
Results Overview
Number of participants without infections on post-op visits 90 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
90 days
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Bacitracin
Nasopore sponge soaked in Bacitracin
Bacitracin: Bacitracin soaked sponge
|
Saline
Saline soaked sponge and oral antibiotics
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
|
Overall Study
COMPLETED
|
113
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bacitracin
n=113 Participants
Nasopore sponge soaked in Bacitracin
Bacitracin: Bacitracin soaked sponge
|
Saline
n=113 Participants
Nasopore sponge soaked in saline
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=226 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=113 Participants
|
113 Participants
n=113 Participants
|
226 Participants
n=226 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=226 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=113 Participants
|
49 Participants
n=113 Participants
|
98 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=113 Participants
|
64 Participants
n=113 Participants
|
128 Participants
n=226 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
113 participants
n=113 Participants
|
113 participants
n=113 Participants
|
226 participants
n=226 Participants
|
PRIMARY outcome
Timeframe: 90 daysNumber of participants without infections on post-op visits 90 days.
Outcome measures
| Measure |
Bacitracin
n=113 Participants
Bacitracin soaked sponge
|
Saline
n=113 Participants
Saline soaked sponge and oral antibiotics
|
|---|---|---|
|
Rate of Infection
|
113 Participants
|
113 Participants
|
Adverse Events
Bacitracin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place