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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine Swabs | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nahid Y. Vidal, M.D. | Mayo Clinic in Rochester | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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.
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| Staphylococcus nasal swab | Diagnostic Test | Undergo a nasal swab to identify patients with preoperative nasal Staphylococcus aureus colonization |
|
| Antibiotic | Drug | 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) |
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|
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D000900 | Anti-Bacterial Agents |
| D000658 | Amoxicillin |
| D017963 | Azithromycin |
| D017291 | Clarithromycin |
| D002506 | Cephalexin |
| D002981 | Clindamycin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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