Trial Outcomes & Findings for Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip (NCT NCT00957827)
NCT ID: NCT00957827
Last Updated: 2019-04-16
Results Overview
Presence or absence of infection
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
one week
Results posted on
2019-04-16
Participant Flow
low enrollment and data not analyzed, patient lost to follow-up.
Participant milestones
| Measure |
Keflex
keflex 500mg twice a day for five days
keflex: keflex 500 mg BID 5 days
|
Placebo
placebo 500mg twice a day for five days
placebo: placebo BID for five days
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip
Baseline characteristics by cohort
| Measure |
Keflex
n=2 Participants
keflex 500mg twice a day for five days
keflex: keflex 500 mg BID 5 days
|
Placebo
n=2 Participants
placebo 500mg twice a day for five days
placebo: placebo BID for five days
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: one weekPopulation: Not evaluated due to low enrollment/This should be reflected in all data fields
Presence or absence of infection
Outcome measures
Outcome data not reported
Adverse Events
Keflex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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