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

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ClinicalTrials.gov Identifier: NCT00957827
Recruitment Status : Terminated (Not enough subject enrolled)
First Posted : August 12, 2009
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Through-and-through Lip Lacerations Drug: keflex Drug: placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. infection [ Time Frame: one week ]

Secondary Outcome Measures :
  1. scar formation [ Time Frame: six months ]


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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957827


Locations
United States, Pennsylvania
Hopital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Carrie Sims, M.D. University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00957827     History of Changes
Other Study ID Numbers: 809859
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Anti-Bacterial Agents
Cephalexin
Anti-Infective Agents