Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Sponsor

Carilion Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04580472

Collaborator

(none)

1,600

Enrollment

Location

Arms

Anticipated Duration (Months)

69.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: Cephalexin Other: Placebo capsules	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Prevention

Official Title:

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo - leg If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.	Other: Placebo capsules Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: Antibiotic- leg The administration time of the oral antibiotics will be 30 minutes prior to incision in the leg group. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered	Drug: Cephalexin 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. Other Names: Clindamycin hydrochloride
Placebo Comparator: Placebo- nose If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.	Other: Placebo capsules Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: Antibiotic- nose The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the nose. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.	Drug: Cephalexin 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. Other Names: Clindamycin hydrochloride
Placebo Comparator: Placebo- ear If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.	Other: Placebo capsules Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: Antibiotic- ear The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the ear. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.	Drug: Cephalexin 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. Other Names: Clindamycin hydrochloride

Outcome Measures

Primary Outcome Measures

Development of surgical site infection within 30 days of surgery [30 days]
Rate of surgical site infection occurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.