Antibiotic Prophylaxis for Simple Hand Lacerations
Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
1 other identifier
interventional
73
1 country
3
Brief Summary
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
November 4, 2014
CompletedNovember 7, 2014
November 1, 2014
2 years
June 29, 2010
January 3, 2014
November 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Presence of Wound Infection
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
2 weeks
Study Arms (3)
clindamycin
ACTIVE COMPARATORclindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
cepahlexin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kings County Hospital Center
Brooklyn, New York, 11203, United States
State University of New York, Downstate Medical Center
Brooklyn, New York, 11203, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shahriar Zehtabchi
- Organization
- SUNY Downstate Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
shahriar zehtabchi, MD
State University of New York - Downstate Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Emergency Medicine
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 1, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 7, 2014
Results First Posted
November 4, 2014
Record last verified: 2014-11