Trial record 6 of 111 for:    Open Studies | "Lacerations"

Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00957827
First received: August 11, 2009
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

Facial lacerations are a commonly encountered problem in the emergency department. Despite this, few original articles have been written concerning the management of lacerations of the lip which communicate with the oral cavity. Specifically, no study has been able to definitively show whether the use of antibiotics for these wounds decreases the infection rate. These cutaneous wounds are a unique type of laceration because they are continuously contaminated with oropharyngeal flora. Contaminated wounds result in larger, less cosmetic scars. Scars which involve the face have been shown to have a negative psychological impact. In this study, the investigators aim to determine whether the use of antibiotics decrease the rate of infection in lacerations of the lip which communicate with the oral cavity. Patients will be randomized to one of two currently practiced therapies. Patients will receive either cephalexin or no treatment following the repair of their through-and-through lip lacerations to determine whether antibiotics decrease the infection rate in these wounds.


Condition Intervention
Through-and-through Lip Lacerations
Drug: keflex
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • infection [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • scar formation [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: keflex
keflex 500mg twice a day for five days
Drug: keflex
keflex 500 mg BID 5 days
Placebo Comparator: placebo Drug: placebo
placebo BID for five days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any individual who presents with a through-and-through laceration of the lip within twenty-four hours of injury

Exclusion Criteria:

  • patients less than eighteen years of age
  • pregnancy
  • currently taking antibiotics
  • animal or human bites
  • wounds greater than 24 hours old
  • diabetic patients
  • immune compromised patients
  • patients who require antibiotics for other sustained injuries
  • patients with an allergy to penicillin or cephalosporin will be excluded if randomized to the cephalexin treatment group
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957827

Contacts
Contact: Joli Chou, M.D., D.M.D. 215 662-3580 joli.chou@uphs.upenn.edu
Contact: Eric Granquist, M.D., D.M.D. 215 880-7568 eric.granquist@uphs.upenn.edu

Locations
United States, Pennsylvania
Hopital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joli Chou, M.D., D.M.D.    215-662-3580    eric.granquist@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Carrie Sims, M.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Carrie Sims, University of Pennsylvania Health System
ClinicalTrials.gov Identifier: NCT00957827     History of Changes
Other Study ID Numbers: 809859
Study First Received: August 11, 2009
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Anti-Bacterial Agents
Cephalexin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 23, 2014