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Antibiotic Prophylaxis for Simple Hand Lacerations

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ClinicalTrials.gov Identifier: NCT01155154
Recruitment Status : Terminated
First Posted : July 1, 2010
Results First Posted : November 4, 2014
Last Update Posted : November 7, 2014
Sponsor:
Collaborators:
Staten Island University Hospital
Kings County Hospital Center
Information provided by (Responsible Party):
Shahriar Zehtabchi, State University of New York - Downstate Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Simple Hand Lacerations
Interventions Drug: cephalexin
Drug: clindamycin
Drug: placebo
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clindamycin Cepahlexin Placebo
Hide Arm/Group Description

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

cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days placebo: Two placebo capsules every 6 hours for 7 days
Period Title: Overall Study
Started 25 24 24
Completed 25 24 24
Not Completed 0 0 0
Arm/Group Title Clindamycin Cepahlexin Placebo Total
Hide Arm/Group Description

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

cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days placebo: Two placebo capsules every 6 hours for 7 days Total of all reporting groups
Overall Number of Baseline Participants 25 24 24 73
Hide Baseline Analysis Population Description
The median age of the subjects was 40 years (quartiles: 29, 53), and 71% were male (n=52).
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 24 participants 73 participants
39
(26 to 56)
42
(32 to 58)
40
(29 to 52)
41
(29 to 55.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 24 participants 73 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  92.0%
20
  83.3%
20
  83.3%
63
  86.3%
>=65 years
2
   8.0%
4
  16.7%
4
  16.7%
10
  13.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 24 participants 73 participants
Female
10
  40.0%
6
  25.0%
5
  20.8%
21
  28.8%
Male
15
  60.0%
18
  75.0%
19
  79.2%
52
  71.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 24 participants 73 participants
25 24 24 73
1.Primary Outcome
Title Number of Participants With Presence of Wound Infection
Hide Description Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clindamycin Cepahlexin Placebo
Hide Arm/Group Description:

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

cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
placebo: Two placebo capsules every 6 hours for 7 days
Overall Number of Participants Analyzed 25 24 24
Measure Type: Number
Unit of Measure: participants
0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clindamycin Cepahlexin Placebo
Hide Arm/Group Description

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

cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days placebo: Two placebo capsules every 6 hours for 7 days
All-Cause Mortality
Clindamycin Cepahlexin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Clindamycin Cepahlexin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clindamycin Cepahlexin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      1/24 (4.17%)      1/24 (4.17%)    
Cardiac disorders       
palpitation   1/25 (4.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders       
diarrhea   1/25 (4.00%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1
Metal After-taste in th mouth   1/25 (4.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders       
dizziness   0/25 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shahriar Zehtabchi
Organization: SUNY Downstate Medical Center
Phone: 718-245-2973
EMail: shahriar.zehtabchi@downstate.edu
Layout table for additonal information
Responsible Party: Shahriar Zehtabchi, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT01155154    
Other Study ID Numbers: 09-130
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: January 3, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 7, 2014