Surgical Site Infection
Conditions
Brief summary
The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.
Interventions
DRUGCephalexin
If randomized to the antibiotic group, a single dose of cephalexin or clindamycin hydrochloride (if concern for previous allergy to Cephalexin) will be given prior to surgery.
OTHERPlacebo capsules
Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will not be told if they are receiving the antibiotic or placebo. Dermatologic surgeons who are performing the surgery and assessing for surgical site infections will be blinded to which arm of the study the patient is randomized. In order to accomplish this, study nurses will be responsible for randomizing each participant and will administer the antibiotic or placebo to each participant after each patient has consented and after the dermatologic surgeon has placed the order for "cephalexin/placebo" or "clindamycin/placebo" (based on patient's allergies) in the electronic medical record.
Intervention model description
Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). These doses for cephalexin and clindamycin hydrochloride are standard doses for adults. The administration time of the oral antibiotics (as well for placebo group) will be 5-15 minutes prior to surgery in the nose and ear group and 30 minutes prior incision in the leg group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * presenting to Carilion Clinic Dermatology and Mohs surgery in Roanoke, VA at Riverside 1 * suspected to undergo a single-staged repair including a skin flap or graft on the nose * OR suspected to undergo single-staged repair including a skin graft or flap or wedge resection 1 on the ear * OR undergoing Mohs with closure or partial closure or surgical excision on the lower extremity below the knee
Exclusion criteria
* patients with intellectual or mental impairment affecting ability to give informed consent * use of any antibiotic (other than intervention) within 48 hours of the surgery suspected infection at time of surgery * inability to take cephalexin or clindamycin hydrochloride due to allergy or intolerance current inflammatory skin disease affecting the surgical site * Patients undergoing concurrent surgery to oral or nasal mucosa * Patients who have had a recent prosthetic joint surgery within two years and have been told they require antibiotic prophylaxis. * Patients who are currently pregnant, concerned they could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by a birth control method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of surgical site infection within 30 days of surgery | 30 days | Rate of surgical site infection occurrence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana Phillips, MD
Carilion Clinic Dermatology and Mohs Surgery
Outcome results
None listed