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The Use of Prophylactic Antibiotics In the Management of Dog Bites

Information source: Stanford University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bite; Wound; Infection

Intervention: Augmentin (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
James V Quinn, MD MS, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Wound infection

Secondary outcome: side effects of medication

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Stanford University Medical Center, Stanford, California 94305, United States

UCSF Medical Center, San Francisco, California 94143, United States

Mills Peninsula Hospital, Burlingame, California, United States

Additional Information

Starting date: August 2003
Ending date: November 2005
Last updated: December 1, 2006

Page last updated: June 20, 2008

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