The Use of Prophylactic Antibiotics In the Management of Dog Bites

Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185939
• Other study ID #: K23AR002137
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: December 1, 2006
• Start date: August 2003
• Est. completion date: November 2005

Study information

• Verified date: December 2006
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bite
• Infection
• Wound

Intervention

Drug:
• Augmentin

Locations

Country	Name	City	State
United States	Mills Peninsula Hospital	Burlingame	California
United States	UCSF Medical Center	San Francisco	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection
Secondary	side effects of medication