Antibiotic Prophylaxis for Simple Hand Lacerations

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

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

Study Overview

• Status: Terminated
• Conditions: Simple Hand Lacerations
• Intervention / Treatment: Drug: clindamycin; Drug: cephalexin; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Kings County Hospital Center
    • Brooklyn, New York, United States, 11203
      • State University of New York, Downstate Medical Center
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Collaborators: Staten Island University Hospital; Kings County Hospital Center
• Investigators: Principal Investigator: shahriar zehtabchi, MD, State University of New York - Downstate Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Antibiotics; infection; hand; antibacterial agents; wounds and lacerations
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin
• Other Study ID Numbers: 09-130