Antibiotic Prophylaxis for Simple Hand Lacerations
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| ClinicalTrials.gov Identifier: NCT01155154 |
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Recruitment Status :
Terminated
First Posted : July 1, 2010
Results First Posted : November 4, 2014
Last Update Posted : November 7, 2014
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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
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Brief Summary:
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Simple Hand Lacerations | Drug: cephalexin Drug: clindamycin Drug: placebo | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 73 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | February 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: clindamycin
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
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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 |
| Placebo Comparator: Placebo |
Drug: placebo
Two placebo capsules every 6 hours for 7 days |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155154
Locations
| United States, New York | |
| Kings County Hospital Center | |
| Brooklyn, New York, United States, 11203 | |
| State University of New York, Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
Sponsors and Collaborators
State University of New York - Downstate Medical Center
Staten Island University Hospital
Kings County Hospital Center
Investigators
| Principal Investigator: | shahriar zehtabchi, MD | State University of New York - Downstate Medical Center |
| Responsible Party: | Shahriar Zehtabchi, Professor of Emergency Medicine, State University of New York - Downstate Medical Center |
| ClinicalTrials.gov Identifier: | NCT01155154 |
| Other Study ID Numbers: |
09-130 |
| First Posted: | July 1, 2010 Key Record Dates |
| Results First Posted: | November 4, 2014 |
| Last Update Posted: | November 7, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Shahriar Zehtabchi, State University of New York - Downstate Medical Center:
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wounds and lacerations hand infection Antibiotics antibacterial agents |
Additional relevant MeSH terms:
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Lacerations Wounds and Injuries Clindamycin Clindamycin palmitate Clindamycin phosphate Cephalexin |
Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |