The Use of Prophylactic Antibiotics In the Management of Dog Bites - Full Text View

Sponsor:	Stanford University
Collaborator:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00185939

Purpose

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	Intervention	Phase
Bite Wound Infection	Drug: Augmentin	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Amoxicillin-potassium clavulanate combination

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Wound infection

Secondary Outcome Measures:

side effects of medication

Estimated Enrollment:	125
Study Start Date:	August 2003
Estimated Study Completion Date:	November 2005

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.

Eligibility

Genders Eligible for Study:	Both
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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185939

Locations

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

Principal Investigator:

James V Quinn, MD MS

Stanford University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00185939 History of Changes
Other Study ID Numbers:	K23- AR02137
Study First Received:	September 12, 2005
Last Updated:	December 1, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stanford University:

dog bites
infection
prophylactic antibiotics
cost effectiveness

Additional relevant MeSH terms:

Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012