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Through-and-through Lip LacerationsNCT00957827

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

A study testing keflex in people with Through-and-through Lip Lacerations, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Through-and-through Lip Lacerations
What is being tested?
keflex
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteUnited States
Study dates
Aug 2009to Aug 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • patients less than eighteen years of age
  • pregnancy
  • currently taking antibiotics
  • animal or human bites
  • wounds greater than 24 hours old
  • diabetic patients
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hopital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Being tested
keflex, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • keflexDrug

    Also called cephalexin

    keflex 500 mg BID 5 days

  • placeboDrug

    placebo BID for five days

Study groups in NCT00957827
Study groupRoleWhat they receive
keflexExperimentalkeflex 500mg twice a day for five days
Receives: Drug: keflex
placeboPlacebo comparatorplacebo 500mg twice a day for five days
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection

    Presence or absence of infection

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionAug 2011
  4. Study completionAug 2011

Why it stopped: Not enough subject enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00957827
Sponsor's protocol ID
809859
Status last verified
Mar 2019
First submitted
11 Aug 2009
Last updated
16 Apr 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing keflex in people with Through-and-through Lip Lacerations, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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