Antibiotic Prophylaxis for Simple Hand Lacerations

Not Applicable

Terminated

• Conditions: Simple Hand Lacerations
• Interventions: Drug: cephalexin; Drug: placebo; Drug: clindamycin

• Registration Number: NCT01155154
• Lead Sponsor: State University of New York - Downstate Medical Center

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-07-01
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2014-01-03
• Results First Submitted QC: 2014-10-28
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Results First Posted: 2014-11-04
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cepahlexin	cephalexin	-
Placebo	placebo	-
clindamycin	clindamycin	clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Presence of Wound Infection	2 weeks	Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.

Trial Locations

Locations (3)

Kings County Hospital Center; 🇺🇸 Brooklyn, New York, United States

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

State University of New York, Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States