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

Skin Cancer Clinical Trial

Official title:

Efficacy of Intranasal Povidone Iodine Swab Versus Oral Antibiotic Prophylaxis to Prevent Surgical Site Infections in Patients Undergoing Mohs Micrographic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207786
• Other study ID #: 23-009869
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2030

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Jorge A. Rios Duarte, M.D.
• Phone: 507-293-1043
• Email: RiosDuarte.Jorge[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1532
• Est. completion date: May 2030
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Cancer Face
• Skin Neoplasms
• Surgical Wound Infection

Intervention

Other:
• 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.

Diagnostic Test:
• Staphylococcus nasal swab
Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization

Drug:
• 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)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)	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.	30 days after MMS