Nasal Iodine Swab Versus Oral Antibiotic to Prevent Surgical Site Infection After Undergoing Mohs Micrographic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2030-05-31

Brief Summary

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The purpose of this study is to compare surgical site infection rates for patients treated with Mohs micrographic surgery after bilateral nasal swab with povidone iodine versus standard treatment including the use of a standardized oral antibiotic prophylaxis protocol.

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Detailed Description

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Conditions

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Skin Cancer Skin Cancer Face Malignant Cutaneous Adnexal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized, open-label, single site clinical trial will be comprised of 2 comparison groups. Treatment arm 1 will be patients undergoing MMS for malignant cutaneous neoplasms receiving nasal povidone-iodine swabs prior to skin reconstruction. Treatment arm 2 will be patients undergoing MMS for malignant cutaneous neoplasms randomized to receive standard of care.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Povidone Iodine nasal swab

Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction.

Group Type EXPERIMENTAL

Povidone-Iodine Swabs

Intervention Type OTHER

Undergo nasal swab of both nostrils for 30 seconds into each nostril, allowing two minutes to dry, immediately (e.g. within 30 minutes) prior to performing skin reconstruction.

Staphylococcus nasal swab

Intervention Type DIAGNOSTIC_TEST

Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization

Oral antibiotic prophylaxis protocol (usual care)

Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive standard of care, including the provision of an oral anti-staphylococcal antibiotic per the standardized Antibiotic Prophylaxis protocol currently used for clinical decision making in Dermatologic Surgery at Mayo Clinic Rochester.

Group Type OTHER

Staphylococcus nasal swab

Intervention Type DIAGNOSTIC_TEST

Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization

Antibiotic

Intervention Type DRUG

Receive an oral anti-staphylococcal antibiotic (e.g. oral cephalexin) with standard dosing only if indicated for antibiotic prophylaxis per the Mayo Clinic Dermatologic Surgery Antibiotic Prophylaxis protocol that is currently standard practice for patients undergoing Mohs micrographic surgery (MMS)

Interventions

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Povidone-Iodine Swabs

Undergo nasal swab of both nostrils for 30 seconds into each nostril, allowing two minutes to dry, immediately (e.g. within 30 minutes) prior to performing skin reconstruction.

Intervention Type OTHER

Staphylococcus nasal swab

Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization

Intervention Type DIAGNOSTIC_TEST

Antibiotic

Receive an oral anti-staphylococcal antibiotic (e.g. oral cephalexin) with standard dosing only if indicated for antibiotic prophylaxis per the Mayo Clinic Dermatologic Surgery Antibiotic Prophylaxis protocol that is currently standard practice for patients undergoing Mohs micrographic surgery (MMS)

Intervention Type DRUG

Other Intervention Names

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Betadine Iodophore Iodopovidone Amoxicillin Azithromycin/clarithromycin Cephalexin Clindamycin Trimethoprim-sulfamethoxazole

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant, non-lactating/breastfeeding, non-incarcerated, English-speaking persons undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms and receiving same-day defect repair by the MMS-performing surgeon
* Able to provide written informed consent prior to initiation of any study-specific procedures
* Able to swallow, retain, and absorb oral medications
* All malignant cutaneous neoplasms will be included

Exclusion Criteria

* On antibiotic treatment or established intolerance or contraindication to povidone-iodine
* Allergy to specific oral antibiotics that are utilized as part of the Mayo Clinic Antibiotic Prophylaxis protocol (cefalexin, azithromycin, clindamycin)
* Requiring oral antibiotic therapy for prophylaxis postoperative infectious endocarditis or hematogenous total joint infection
* Cases where skin reconstruction is performed with non-sterile gloves
* Patients with lesions on the legs, as dilute vinegar soaks are standard practice and this would be a confounder for preventing surgical site infection
* Patients at increased risk for severe infections, including patients on immunosuppressive medications and biologics, patients with a history of HIV infection, chronic lymphocytic leukemia, immunodeficiency syndromes, as well as patients with insulin-dependent diabetes mellitus

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No