Antibiotic Prophylaxis for Simple Hand Lacerations

State University of New York - Downstate Medical Center

Status: Terminated

Conditions: Simple Hand Lacerations

Treatments: Drug: clindamycin; Drug: cephalexin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01155154

09-130

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 3 patient groups, including a placebo group

clindamycin

Active Comparator group

Description:

clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days

Treatment:

Drug: clindamycin

cepahlexin

Active Comparator group

Treatment:

Drug: cephalexin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo