Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip
Recruitment status was Recruiting
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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 |
- infection [ Time Frame: one week ] [ Designated as safety issue: No ]
- 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 |
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| 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 |
| 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 | |
| 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 |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013