Antibiotic Prophylaxis for Simple Hand Lacerations

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

Detailed Description
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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.

Official Title
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Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations

Conditions
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Simple Hand Lacerations

Intervention / Treatment
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* Drug: cephalexin
* Drug: clindamycin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clindamycin<br>clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days | Drug: clindamycin<br>* 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days<br>|
| Active Comparator: cepahlexin<br> | Drug: cephalexin<br>* 500 mg (two 250 mg capsules) every 6 hours for 7 days<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Two placebo capsules every 6 hours for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wounds and lacerations, hand, infection, Antibiotics, antibacterial agents