The Use of Prophylactic Antibiotics In the Management of Dog Bites

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT00185939

Collaborator

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

125

Enrollment

Locations

Duration (Months)

41.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Prevention

Study Start Date :

Aug 1, 2003

Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Wound infection []

Secondary Outcome Measures

side effects of medication []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mills Peninsula Hospital	Burlingame	California	United States
2	UCSF Medical Center	San Francisco	California	United States	94143
3	Stanford University Medical Center	Stanford	California	United States	94305