Skin CancerNCT06207786
Nasal Iodine Swab Versus Oral Antibiotic to Prevent Surgical Site Infection After Undergoing Mohs Micrographic Surgery
A study testing Povidone-Iodine Swabs, Staphylococcus nasal swab and Antibiotic in people with Skin Cancer and Skin Cancer Face, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Skin Cancer Face, Malignant Cutaneous Adnexal Neoplasm
- What is being tested?
- Povidone-Iodine Swabs, Staphylococcus nasal swab and Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to May 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efficacy of Intranasal Povidone Iodine Swab Versus Oral Antibiotic Prophylaxis to Prevent Surgical Site Infections in Patients Undergoing Mohs Micrographic Surgery
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.
- Being tested
- Povidone-Iodine Swabs, Staphylococcus nasal swab, Antibiotic
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine SwabsOther
Also called Betadine, Iodophore, Iodopovidone
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.
Staphylococcus nasal swabDiagnostic test
Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization
AntibioticDrug
Also called Amoxicillin, Azithromycin/clarithromycin, Cephalexin, Clindamycin
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)
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine nasal swab | Experimental | Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction. Receives: Other: Povidone-Iodine Swabs; Diagnostic Test: Staphylococcus nasal swab |
| Oral antibiotic prophylaxis protocol (usual care) | Other | 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. Receives: Diagnostic Test: Staphylococcus nasal swab; Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after MMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Sep 2024 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Why it stopped: Lack of resources to support the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nahid Y. Vidal, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207786
- Sponsor's protocol ID
- 23-009869
- Status last verified
- Nov 2024
- First submitted
- 5 Jan 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intranasal Povidone Iodine Swab Versus Oral Antibiotic Prophylaxis to Prevent Surgical Site Infections in Patients Undergoing Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT06207786
- Acronym / sponsor ID
- 23-009869
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources to support the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine nasal swab | Experimental | Other: Povidone-Iodine Swabs, Diagnostic Test: Staphylococcus nasal swabPatients 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) | Other | Diagnostic Test: Staphylococcus nasal swab, Drug: AntibioticPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-Iodine SwabsAlso: Betadine, Iodophore, IodopovidoneUndergo 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. | Other | Povidone Iodine nasal swab |
| Staphylococcus nasal swabUndergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization | Diagnostic test | Oral antibiotic prophylaxis protocol (usual care), Povidone Iodine nasal swab |
| AntibioticAlso: Amoxicillin, Azithromycin/clarithromycin, Cephalexin, ClindamycinReceive 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) | Drug | Oral antibiotic prophylaxis protocol (usual care) |
Primary outcome
Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahid Y. Vidal, M.D. principal investigator
Mayo Clinic in Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine Swabs, Staphylococcus nasal swab and Antibiotic in people with Skin Cancer and Skin Cancer Face, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI) (time frame: 30 days after MMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.