The Use of Prophylactic Antibiotics In the Management of Dog Bites

NCT ID: NCT00185939

Last Updated: 2006-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bite Wound Infection

Keywords

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dog bites infection prophylactic antibiotics cost effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Augmentin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Principal Investigators

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James V Quinn, MD MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Mills Peninsula Hospital

Burlingame, California, United States

Site Status

UCSF Medical Center

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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K23AR002137

Identifier Type: NIH

Identifier Source: org_study_id

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