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Antibiotic Prophylaxis for Simple Hand Lacerations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by State University of New York - Downstate Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Staten Island University Hospital
Kings County Hospital Center
Information provided by:
State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT01155154
First received: June 29, 2010
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
  Purpose

Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?


Condition Intervention
Simple Hand Lacerations
 Drug: cephalexin
Drug: clindamycin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by State University of New York - Downstate Medical Center:

Primary Outcome Measures:
  • Wound Infection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.


Secondary Outcome Measures:
  • Risk of side effects from antibiotics [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: clindamycin
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
 Drug: clindamycin
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
Active Comparator: cepahlexin Drug: cephalexin
500 mg (two 250 mg capsules) every 6 hours for 7 days
Placebo Comparator: Placebo Drug: placebo
Two placebo capsules every 6 hours for 7 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155154

Contacts
Contact: shahriar zehtabchi, MD 718-245-2973 shahriar.zehtabchi@downstate.edu
Contact: Nicole Berwald, MD 516-8851-575 nicole.berwald@gmail.com

Locations
United States, New York
State University of New York, Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Shahriar zehtabchi, MD     718-245-2973     shahriar.zehtabchi@downstate.edu    
Principal Investigator: shahriar zehtabchi, MD            
Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
Contact: shahriar zehtabchi, MD     718-245-2973     shahriar.zehtabchi@downstate.edu    
Principal Investigator: shahriar zehtabchi, MD            
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Nicole Berwald, MD         nicole.berwald@gmail.com    
Principal Investigator: Nicole Berwald, MD            
Sponsors and Collaborators
State University of New York - Downstate Medical Center
Staten Island University Hospital
Kings County Hospital Center
Investigators
Principal Investigator: shahriar zehtabchi, MD State University of New York - Downstate Medical Center
  More Information

No publications provided

Responsible Party: Shahriar Zehtabchi, MD, Department of Emergency Medicine, State University of New York, Downstate Medical Center
ClinicalTrials.gov Identifier: NCT01155154     History of Changes
Other Study ID Numbers: 09-130
Study First Received: June 29, 2010
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Downstate Medical Center:
wounds and lacerations
hand
infection
Antibiotics
antibacterial agents

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Anti-Bacterial Agents
Cephalexin
Clindamycin
Clindamycin-2-phosphate
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013