Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00957827 |
| Other study ID # |
809859 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2009 |
| Est. completion date |
August 2011 |
Study information
| Verified date |
March 2019 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
