Antibiotic Prophylaxis for Simple Hand Lacerations

This study has been terminated.
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
ClinicalTrials.gov Identifier:
NCT01155154
First received: June 29, 2010
Last updated: May 30, 2013
Last verified: May 2013
  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:


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
Study Completion Date: February 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
State University of New York, Downstate Medical Center
Brooklyn, New York, United States, 11203
Kings County Hospital Center
Brooklyn, New York, United States, 11203
Staten Island University Hospital
Staten Island, New York, United States, 10305
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, Professor 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: May 30, 2013
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 palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014