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

Condition(s) targeted: Through-and-through Lip Lacerations

Intervention: keflex (Drug); peridex (Drug); placebo (Drug)

Phase: N/A

Status: Not yet 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

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 three currently practiced therapies. Patients will receive either cephalexin, chlorhexidine or no treatment following the repair of their through-and-through lip lacerations to determine whether antibiotics decrease the infection rate in these wounds.

Official title: Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: infection

Secondary outcome: scar formation

Detailed description: Facial lacerations are commonly encountered problem in trauma and emergency room patients 1,2. Soft tissue trauma of the face can cause significant psychological impact 4. Wound care and the need to minimize scarring is particularly important in this region 4. There have been many studies evaluating the management of soft tissue injuries in general 1, 5. For example, simple lacerations of the hand do not benefit from antibiotic therapy 5. The need for antibiotics for full thickness lacerations of the lip, however, has received little attention 3. 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 3.

A review of the literature found only four original articles addressing the topic of oral antibiotic prophylaxis3. 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 6. Despite these flaws, the study demonstrated a non-significant trend toward benefit with antibiotics 6. Of interest, the author noted all wounds older than 24 hours not treated with antibiotics became infected 6.

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 7. 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) 7. None of the patients with mucosa-only wounds developed wound infections; all infections were seen in patients with "through-and-through" lacerations 7. Despite this, the authors concluded that the role of prophylactic antibiotics is questionable in preventing local infection 7.

The third article was a prospective, randomized study in the pediatric population evaluating all intra-oral lacerations 8. 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)8. 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 8.

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 9. 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) 9. 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) 9. 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) 9. 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 9.

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 wounds10-14. Many other text books, on the other hand, do not address this topic at all10-14. 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. 9 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 15.

The second treatment group chosen was chlorhexidine gluconate 0. 12% solution. This medication is typically used to treat periodontal disease, but has also been studied as a prophylactic agent for perioperative maxillofacial surgery. Significant adverse reactions (>10%) include tooth staining when used longer than a week. 16 This side-effect is reversible with dental cleanings. In a retrospective review of periodontal procedures, the prophylactic use of chlorhexidine rinse showed a lower infection rate for these intraoral procedures17. In addition, it has been suggested in emergency medicine literature, that Cholrhexidine may be a useful agent in the prevention of infection in these wounds. 18 We feel that prospective study of this agent is warranted.

Current practice concerning the use of antibiotics for oral-cutaneous wounds varies greatly10-14. Many textbooks either do not address the topic or cite inconclusive evidence10-14. A thorough search of the literature revealed only four original articles 3. No article was able to produce significant results and the trends and recommendations were mixed 3. Currently, there is no consensus regarding the treatment of oral cutaneous wounds and patients are treated with oral antibiotics, topical antibacterials, or local wound care depending on the treating physician's preference 3. It is important to determine the best treatment protocol for these unique wounds.

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

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

Starting date: August 2009
Ending date: August 2011
Last updated: August 12, 2009