The Use of Prophylactic Antibiotics In the Management of Dog Bites

Phase 2

Completed

• Conditions: Bite; Wound; Infection

• Registration Number: NCT00185939
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2005-11
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-01
• Last Update Posted: 2006-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wound infection

Secondary Outcome Measures

Name	Time	Method
side effects of medication

Trial Locations

Locations (3)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Mills Peninsula Hospital; 🇺🇸 Burlingame, California, United States

UCSF Medical Center; 🇺🇸 San Francisco, California, United States