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

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Mayo Clinic

Status

Not yet enrolling

Conditions

Malignant Cutaneous Adnexal Neoplasm
Skin Cancer Face
Skin Cancer

Treatments

Diagnostic Test: Staphylococcus nasal swab
Other: Povidone-Iodine Swabs
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)

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:
Other: Povidone-Iodine Swabs
Diagnostic Test: Staphylococcus nasal swab
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

Trial contacts and locations

1

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Central trial contact

Jorge A. Rios Duarte, M.D.

Data sourced from clinicaltrials.gov

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