Malignant Cutaneous Adnexal Neoplasm, Skin Cancer, Skin Cancer Face
Conditions
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.
Interventions
OTHERPovidone-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.
DIAGNOSTIC_TESTStaphylococcus nasal swab
Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization
DRUGAntibiotic
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)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed