Trial Outcomes & Findings for Antibiotic Prophylaxis for Simple Hand Lacerations (NCT NCT01155154)
NCT ID: NCT01155154
Last Updated: 2014-11-07
Results Overview
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
2 weeks
Results posted on
2014-11-07
Participant Flow
Participant milestones
| Measure |
Clindamycin
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
|
Cepahlexin
cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
|
Placebo
placebo: Two placebo capsules every 6 hours for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Prophylaxis for Simple Hand Lacerations
Baseline characteristics by cohort
| Measure |
Clindamycin
n=25 Participants
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
|
Cepahlexin
n=24 Participants
cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
|
Placebo
n=24 Participants
placebo: Two placebo capsules every 6 hours for 7 days
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 years
n=99 Participants
|
42 years
n=107 Participants
|
40 years
n=206 Participants
|
41 years
n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
24 participants
n=206 Participants
|
73 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 weeksHand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Outcome measures
| Measure |
Clindamycin
n=25 Participants
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
|
Cepahlexin
n=24 Participants
cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
|
Placebo
n=24 Participants
placebo: Two placebo capsules every 6 hours for 7 days
|
|---|---|---|---|
|
Number of Participants With Presence of Wound Infection
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Clindamycin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cepahlexin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clindamycin
n=25 participants at risk
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
|
Cepahlexin
n=24 participants at risk
cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
|
Placebo
n=24 participants at risk
placebo: Two placebo capsules every 6 hours for 7 days
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
palpitation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Metal After-taste in th mouth
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place