Antibiotic Prophylaxis for Simple Hand Lacerations

Simple Hand Lacerations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01155154
• Other study ID #: 09-130
• Status: Terminated
• Phase: N/A
• First received: June 29, 2010
• Last updated: November 3, 2014
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: November 2014
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations
• Simple Hand Lacerations

Intervention

Drug:
• cephalexin
500 mg (two 250 mg capsules) every 6 hours for 7 days
• clindamycin
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
• placebo
Two placebo capsules every 6 hours for 7 days

Locations

Country	Name	City	State
United States	Kings County Hospital Center	Brooklyn	New York
United States	State University of New York, Downstate Medical Center	Brooklyn	New York
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center	Kings County Hospital Center, Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No