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The Use of Prophylactic Antibiotics In the Management of Dog Bites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185939
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 5, 2006
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Stanford University

Study Description
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Brief Summary:

This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.

By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.


Condition or disease Intervention/treatment Phase
Bite Wound Infection Drug: Augmentin Phase 2 Phase 3

Detailed Description:

This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.

By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : August 2003
Study Completion Date : November 2005
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Wound infection

Secondary Outcome Measures :
  1. side effects of medication

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients including all children and English speaking/reading persons who present with a full thickness dog bite to participating emergency departments will be considered. Non-English speaking/reading subjects for whom we can provide translation for will also be considered.

Exclusion Criteria:

Exclusion Criteria:

  • allergy to penicillin or amoxicillin/clavulanic acid
  • wounds presenting with an active infection (require antibiotics) or greater than 12 hours old.
  • patients with underlying fracture, joint or neurovascular injury, or multiple trauma requiring specialty referral. Specifically any broken skin over a joint will need treatment and be excluded from the study and randomization.
  • patients on immunosuppressive agents, prolonged chronic steroid use (defined as continuous use for > 14 days, 3 times a year) active HIV disease (determined by treating physician on history) or splenectomized. (could skew one group and at risk for overwhelming sepsis and death if infected)
  • patients unwilling or unable to complete the required follow-up, and those unable to provide a contact phone number
Contacts and Locations
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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): NCT00185939


Locations
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United States, California
Mills Peninsula Hospital
Burlingame, California, United States
UCSF Medical Center
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: James V Quinn, MD MS Stanford University
More Information
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ClinicalTrials.gov Identifier: NCT00185939    
Other Study ID Numbers: K23AR002137 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 5, 2006
Last Verified: December 2006
Keywords provided by Stanford University:
dog bites
infection
prophylactic antibiotics
cost effectiveness
Additional relevant MeSH terms:
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Infections
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
 beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action