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

Mayo Clinic

Status: Begins enrollment in 1 month

Conditions: Malignant Cutaneous Adnexal Neoplasm; Skin Cancer Face; Skin Cancer

Treatments: Other: Povidone-Iodine Swabs; Diagnostic Test: Staphylococcus nasal swab; Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06207786

23-009869

Details and patient eligibility

About

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.

Enrollment: 1,532 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,532 participants in 2 patient groups

Povidone Iodine nasal swab

Experimental group

Description:

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

Treatment:

Diagnostic Test: Staphylococcus nasal swab

Other: Povidone-Iodine Swabs

Oral antibiotic prophylaxis protocol (usual care)

Other group

Description:

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.

Treatment:

Drug: Antibiotic

Diagnostic Test: Staphylococcus nasal swab