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Antibiotic Prophylaxis for Simple Hand Lacerations

Primary Purpose

Simple Hand Lacerations

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cephalexin
clindamycin
placebo
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Simple Hand Lacerations focused on measuring wounds and lacerations, hand, infection, Antibiotics, antibacterial agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kings County Hospital Center
  • State University of New York, Downstate Medical Center
  • Staten Island University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

clindamycin

cepahlexin

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
November 3, 2014
Sponsor
State University of New York - Downstate Medical Center
Collaborators
Staten Island University Hospital, Kings County Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01155154
Brief Title
Antibiotic Prophylaxis for Simple Hand Lacerations
Official Title
Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center
Collaborators
Staten Island University Hospital, Kings County Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simple Hand Lacerations
Keywords
wounds and lacerations, hand, infection, Antibiotics, antibacterial agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clindamycin
Arm Type
Active Comparator
Arm Description
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
Arm Title
cepahlexin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
cephalexin
Intervention Description
500 mg (two 250 mg capsules) every 6 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
clindamycin
Intervention Description
300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Two placebo capsules every 6 hours for 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Presence of Wound Infection
Description
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shahriar zehtabchi, MD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
State University of New York, Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

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Antibiotic Prophylaxis for Simple Hand Lacerations

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