The Use of Prophylactic Antibiotics In the Management of Dog Bites

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185939
First received: September 12, 2005
Last updated: December 1, 2006
Last verified: December 2006

September 12, 2005
December 1, 2006
August 2003
Not Provided
Wound infection
Same as current
Complete list of historical versions of study NCT00185939 on ClinicalTrials.gov Archive Site
side effects of medication
Same as current
Not Provided
Not Provided
 
The Use of Prophylactic Antibiotics In the Management of Dog Bites
Not Provided

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Bite
  • Wound
  • Infection
Drug: Augmentin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
November 2005
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185939
K23- AR02137
Not Provided
Not Provided
Stanford University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: James V Quinn, MD MS Stanford University
Stanford University
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP