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

Not Applicable

Withdrawn

• Conditions: Skin Cancer; Malignant Cutaneous Adnexal Neoplasm; Skin Cancer Face
• Interventions: Other: Povidone-Iodine Swabs; Diagnostic Test: Staphylococcus nasal swab; Drug: Antibiotic

• Registration Number: NCT06207786
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-17
• Study Start: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2029-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 1532

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povidone Iodine nasal swab	Povidone-Iodine Swabs	Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction.
Povidone Iodine nasal swab	Staphylococcus nasal swab	Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction.
Oral antibiotic prophylaxis protocol (usual care)	Staphylococcus nasal swab	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.
Oral antibiotic prophylaxis protocol (usual care)	Antibiotic	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.

Primary Outcome Measures

Name	Time	Method
Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)	30 days after MMS	Effectiveness of nasal decolonization will be assessed based on the presence of SSI within 30 days after Mohs micrographic surgery (MMS). SSI is defined by the United States Centers for Disease Control and Prevention as infection of the cutaneous and subcutaneous tissue occurring within 30 days of surgery. Rates of SSI for both treatment arms will be reported.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States