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

Primary Purpose

Surgical Site Infection

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cephalexin

Placebo capsules

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Carilion ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo - leg

Antibiotic- leg

Placebo- nose

Antibiotic- nose

Placebo- ear

Antibiotic- ear

Arm Description

If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.

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

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the 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.

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the 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.

Outcomes

Primary Outcome Measures

Development of surgical site infection within 30 days of surgery

Rate of surgical site infection occurrence

Secondary Outcome Measures

Full Information

NCT ID

NCT04580472

First Posted

September 3, 2020

Last Updated

August 1, 2022

Sponsor

Carilion Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04580472

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo - leg

Arm Type

Placebo Comparator

Arm Description

If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.

Arm Title

Antibiotic- leg

Arm Type

Experimental

Arm Description

Arm Title

Placebo- nose

Arm Type

Placebo Comparator

Arm Description

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.

Arm Title

Antibiotic- nose

Arm Type

Experimental

Arm Description

Arm Title

Placebo- ear

Arm Type

Placebo Comparator

Arm Description

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.

Arm Title

Antibiotic- ear

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cephalexin

Other Intervention Name(s)

Clindamycin hydrochloride

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo capsules

Intervention Description

Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.

Primary Outcome Measure Information:

Title

Development of surgical site infection within 30 days of surgery

Description

Rate of surgical site infection occurrence

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariana Phillips, MD

Phone

540-224-5170

maphillips@carilionclinic.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jane Gay, BA

jagay01@vt.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariana Phillips, MD

Organizational Affiliation

Carilion Clinic Dermatology and Mohs Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carilion Clinic

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariana Phillips

Phone

540-224-5170

maphillips@carilionclinic.org

First Name & Middle Initial & Last Name & Degree

Jane Gay

Phone

5403368811

jagay01@vt.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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