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

  Hide Detailed Description

Detailed Description:

Facial lacerations are commonly encountered problem in trauma and emergency room patients. Soft tissue trauma of the face can cause significant psychological impact. Wound care and the need to minimize scarring is particularly important in this region. There have been many studies evaluating the management of soft tissue injuries in general. For example, simple lacerations of the hand do not benefit from antibiotic therapy. The need for antibiotics for full thickness lacerations of the lip, however, has received little attention. Full thickness lacerations of the lip are defined as wounds that violate the mucosa, underlying muscle and skin (i.e through-and through lacerations). These oral-cutaneous injuries constitute a unique type of injury in that the laceration exposes the skin and underlying soft tissue to microbes of the oral pharynx that are normally encountered only by intact oral mucosa. This represents a uniquely different flora from that typically seen in simple skin lacerations. Because these are contaminated wound, there may be an increased risk for infection and an increased need for prophylactic antibiotics. Currently, there is no consensus on the prophylactic treatment of oral-cutaneous wounds with many physicians prescribing oral antibiotics, others utilizing topical antibacterials, and still others treating with local wound care.

A review of the literature found only four original articles addressing the topic of oral antibiotic prophylaxis. Two of these four original articles suffer serious methodological flaws. The first, published in 1965, was a prospective observational study which was neither blinded, nor specified the type or duration of antibiotic therapy. Despite these flaws, the study demonstrated a non-significant trend toward benefit with antibiotics. Of interest, the author noted all wounds older than 24 hours not treated with antibiotics became infected.

The second article, published in 1970 by Paterson et. was a prospective randomized trial, though the type and duration of antibiotic treatment in the intervention arm was left to the discretion of the treating clinician. The author combined both mucosal only oral lacerations and oral-cutaneous wounds. Wound infection was deemed to be present in 18.5% of patients treated with antibiotics versus 4.3% of those receiving no treatment (RR = 4.32, 95% CI = 1.30 to 14.31). None of the patients with mucosa-only wounds developed wound infections; all infections were seen in patients with "through-and-through" lacerations. Despite this, the authors concluded that the role of prophylactic antibiotics is questionable in preventing local infection.

The third article was a prospective, randomized study in the pediatric population evaluating all intra-oral lacerations. In this study 4.3% of patients treated with prophylactic penicillin had evidence of wound infection at follow-up, versus 8.5% of patients in the control arm (RR = 0.51, 95% CI = 0.10 to 2.65). The authors conclude that given the low background rate of infection in this study (8.5%), their study was markedly underpowered, and severely limited their ability to make any conclusions regarding the efficacy of prophylactic antibiotics.

Finally, in 1989, Steele et al. randomized 62 adult patients presenting within 24 hours of injury to a single emergency department with full-thickness intraoral or "through-and-through" lacerations to either treatment with oral antibiotics (penicillin VK for 5 days) or placebo therapy. Among patients treated with penicillin prophylaxis, 6.7% developed wound infection versus 18.8% in the placebo group (RR = 0.36, 95% CI = 0.08 to 1.63). In a subgroup analysis of patients who were perfectly compliant with therapy by pill counts, there were no infections in the penicillin arm versus 17.9% in the placebo arm (p = 0.054 using two-tailed Fisher exact test). The authors alternatively reported this as a statistically significant finding, using a one-tailed Fisher exact test, which yields a p value of 0.027. Furthermore, in subgroup analysis of "through-and-though" lacerations, 7% (1 out of 14) versus 27% (4 out of 15) of patients developed wound infection in the treatment and placebo groups, respectively (RR = 0.27, 95% CI = 0.03 to 2.12). Overall the authors conclude that while they cannot conclusively recommend prophylactic penicillin for adults with intraoral lacerations treated within 24 hours of injury, though there may be a trend towards benefit 9. They also suggest that patients with "through-and-through" wounds may benefit proportionally more from prophylaxis.

Despite the authors' inability to make conclusive recommendations from the available data, many textbooks cite these references and recommend the routine use of antibiotics for oral-cutaneous wounds. Many other text books, on the other hand, do not address this topic at all. Our study aims to answer the question of whether or not antibiotics reduce wound infection rates in through-and-through lacerations of the lip with a dedicated antibiotic regimen evaluated prospectively.

The type of antibiotic used to prophylactically treat oral-cutaneous wounds also remains controversial among clinicians. Previous studies have utilized penicillin V K. Penicillin, however, does not fully cover the flora typically cultured in infected oral-cutaneous wounds. Cephalexin is well described in the literature as an appropriate choice for oropharyngeal infections and has appropriate skin flora coverage, thereby, making it an ideal antibiotic for the prophylaxis of oral-cutaneous wounds.

Current practice concerning the use of antibiotics for oral-cutaneous wounds varies greatly. Many textbooks either do not address the topic or cite inconclusive evidence. A thorough search of the literature revealed only four original articles. No article was able to produce significant results and the trends and recommendations were mixed. Currently, there is no consensus regarding the treatment of oral cutaneous wounds and patients are treated with oral antibiotics, or local wound care depending on the treating physician's preference. It is important to determine the best treatment protocol for these unique wounds.

  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

ClinicalTrials.gov processed this record on October 22, 2014