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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

Tracking Information
First Submitted Date  ICMJE June 29, 2010
First Posted Date  ICMJE July 1, 2010
Results First Submitted Date  ICMJE January 3, 2014
Results First Posted Date  ICMJE November 4, 2014
Last Update Posted Date November 7, 2014
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
Number of Participants With Presence of Wound Infection [ Time Frame: 2 weeks ]
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Wound Infection [ Time Frame: 2 weeks ]
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Risk of side effects from antibiotics [ Time Frame: 2 weeks ]
Subjects will be examined and questioned in order to identify any signs or symptoms related to the side effects of the study medications (cephalexin or clindamycin).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Prophylaxis for Simple Hand Lacerations
Official Title  ICMJE Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
Brief Summary Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
Detailed Description Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Simple Hand Lacerations
Intervention  ICMJE
  • Drug: cephalexin
    500 mg (two 250 mg capsules) every 6 hours for 7 days
  • Drug: clindamycin
    300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
  • Drug: placebo
    Two placebo capsules every 6 hours for 7 days
Study Arms  ICMJE
  • Active Comparator: clindamycin
    clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
    Intervention: Drug: clindamycin
  • Active Comparator: cepahlexin
    Intervention: Drug: cephalexin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 28, 2014)
73
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2010)
300
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).

Exclusion Criteria:

  • Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
  • Current or recent (within two weeks) use of any antibiotics
  • Allergy to clindamycin or cephalexin
  • Bites (e.g. dog, cat, or human)
  • Lacerations resulted from crush injury
  • Lacerations involving bone, tendon, blood vessel, or nerve
  • Lacerations inflicted more than 12 hours prior to ED visit
  • Pregnant or breast-feeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155154
Other Study ID Numbers  ICMJE 09-130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shahriar Zehtabchi, State University of New York - Downstate Medical Center
Study Sponsor  ICMJE State University of New York - Downstate Medical Center
Collaborators  ICMJE
  • Staten Island University Hospital
  • Kings County Hospital Center
Investigators  ICMJE
Principal Investigator: shahriar zehtabchi, MD State University of New York - Downstate Medical Center
PRS Account State University of New York - Downstate Medical Center
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP