Antibiotic Prophylaxis for Simple Hand Lacerations

• ClinicalTrials.gov Identifier: NCT01155154
• Recruitment Status: Terminated
• First Posted: July 1, 2010
• Results First Posted: November 4, 2014
• Last Update Posted: November 7, 2014
• Sponsor: State University of New York - Downstate Medical Center
• Collaborators: Staten Island University Hospital; Kings County Hospital Center
• Information provided by (Responsible Party): Shahriar Zehtabchi, State University of New York - Downstate Medical Center

Tracking Information

• First Submitted Date: June 29, 2010
• First Posted Date: July 1, 2010
• Results First Submitted Date: January 3, 2014
• Results First Posted Date: November 4, 2014
• Last Update Posted Date: November 7, 2014
• Study Start Date: February 2010
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2014)

Number of Participants With Presence of Wound Infection [ Time Frame: 2 weeks ]

Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.

Original Primary Outcome Measures (submitted: June 29, 2010)

Wound Infection [ Time Frame: 2 weeks ]

Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: June 29, 2010)

Risk of side effects from antibiotics [ Time Frame: 2 weeks ]

Subjects will be examined and questioned in order to identify any signs or symptoms related to the side effects of the study medications (cephalexin or clindamycin).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Antibiotic Prophylaxis for Simple Hand Lacerations
• Official Title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Simple Hand Lacerations

Intervention

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

Study Arms

• Active Comparator: clindamycin
  clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
  Intervention: Drug: clindamycin
• Active Comparator: cepahlexin
  Intervention: Drug: cephalexin
• Placebo Comparator: Placebo
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 28, 2014): 73
• Original Estimated Enrollment (submitted: June 29, 2010): 300
• Actual Study Completion Date: February 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01155154
• Other Study ID Numbers: 09-130
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shahriar Zehtabchi, State University of New York - Downstate Medical Center
• Study 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

• PRS Account: State University of New York - Downstate Medical Center
• Verification Date: November 2014