Antibiotic Prophylaxis for Simple Hand Lacerations
Information source: State University of New York - Downstate Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Simple Hand Lacerations
Intervention: cephalexin (Drug); clindamycin (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: State University of New York - Downstate Medical Center Official(s) and/or principal investigator(s):
shahriar zehtabchi, MD, Principal Investigator, Affiliation: State University of New York - Downstate Medical Center
Overall contact:
shahriar zehtabchi, MD, Phone: 718-245-2973, Email: shahriar.zehtabchi@downstate.edu
Summary
Research Question: In emergency department patients with simple hand cuts, do prophylactic
antibiotics reduce the risk of wound infections?
Clinical Details
Official title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Wound Infection
Secondary outcome: Risk of side effects from antibiotics
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
shahriar zehtabchi, MD, Phone: 718-245-2973, Email: shahriar.zehtabchi@downstate.edu
State University of New York, Downstate Medical Center, Brooklyn, New York 11203, United States; Recruiting
Shahriar zehtabchi, MD, Phone: 718-245-2973, Email: shahriar.zehtabchi@downstate.edu
shahriar zehtabchi, MD, Principal Investigator
Kings County Hospital Center, Brooklyn, New York 11203, United States; Recruiting
shahriar zehtabchi, MD, Phone: 718-245-2973, Email: shahriar.zehtabchi@downstate.edu
shahriar zehtabchi, MD, Principal Investigator
Staten Island University Hospital, Staten Island, New York 10305, United States; Recruiting
Nicole Berwald, MD, Email: nicole.berwald@gmail.com
Nicole Berwald, MD, Principal Investigator
Additional Information
Starting date: February 2010
Last updated: February 14, 2011
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