Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Through-and-through Lip Lacerations
Intervention: keflex (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s): Carrie Sims, M.D., Principal Investigator, Affiliation: University of Pennsylvania
Overall contact: Joli Chou, M.D., D.M.D., Phone: 215 662-3580, Email: joli.chou@uphs.upenn.edu
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.
Clinical Details
Official title: Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: infection
Secondary outcome: scar formation
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
Minimum age: 18 Months.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Joli Chou, M.D., D.M.D., Phone: 215 662-3580, Email: joli.chou@uphs.upenn.edu
Hopital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting Joli Chou, M.D., D.M.D., Phone: 215-662-3580, Email: eric.granquist@uphs.upenn.edu
Additional Information
Starting date: August 2009
Last updated: July 23, 2010
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