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

NCT00957827 | Terminated Results

• 1 other identifier: 809859
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Through-and-through Lip Lacerations

Outcome Measures

Primary Outcomes (1)

• Infection

  Presence or absence of infection

  one week

Study Arms (2)

keflex

EXPERIMENTAL

keflex 500mg twice a day for five days

Drug: keflex

placebo

PLACEBO COMPARATOR

placebo 500mg twice a day for five days

Drug: placebo

Interventions

keflex DRUG

keflex 500 mg BID 5 days

Also known as: cephalexin

keflex

placebo DRUG

placebo BID for five days

placebo

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hopital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Cephalexin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Study terminated secondary to poor enrollment.

Results Point of Contact

• Title: Eric Granquist
• Organization: University of Pennsylvania

eric.granquist@uphs.upenn.edu

215 880-7568

Study Officials

• Carrie Sims, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)