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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Washington University School of Medicine | OTHER |
| Baylor College of Medicine | OTHER |
| Princeton Healthcare System |
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The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Does Hibiclens antibacterial skin cleanser and mupirocin antibacterial ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
Shower with Hibiclens once daily for 5 days prior to the day of surgery and apply mupirocin to the nostrils twice daily for 5 days prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week and 4-week post-operation.
Participants randomized to the control group (standard of care) will:
NOT apply the topical antibacterials prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week intervals for 1 month after surgery.
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Does Hibiclens antibacterial skin cleanser and mupirocin ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
Participants randomized to the control group (standard of care) will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This group will be prophylactically treated with topical antibiotics every day for 5 days prior to surgery. Participants will shower with Hibiclens antiseptic skin cleanser once daily and apply mupirocin ointment to the nares twice daily, in the morning and evening. |
|
| Control Group | No Intervention | This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate (4%) | Drug | Chlorhexidine 4% solution will be applied from the neck down (avoiding the face, penis, and vagina), allowed to sit on the skin for one minute, then rinsed off in the shower every day for 5 days prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Surgical Site Wound Infection | Signs of infection, including erythema, edema, drainage, and delayed healing, will be visually determined by study physicians with photographs of the surgical site collected from study participants. All patients will be followed up with a phone call at 1 month to monitor for any adverse events and additional signs of infection including pain, tenderness, warmth, and foul odor at the surgical site. | From date of surgery to 1-month post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Pathogens Present in Surgical Site | Study participants with signs of infection, as determined by the study physicians from photos of the wound, will return to the office for a wound culture to determine the type of pathogen causing the infection. | From date of surgery to 1-month post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naomi Lawrence, MD | Contact | (856) 596-3040 | lawrence-naomi@cooperhealth.edu | |
| Faria Nusrat, BS | Contact | (856) 596-3040 | nusrat-faria@cooperhealth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Dermatologic Surgery at Cooper University Health Care | Recruiting | Marlton | New Jersey | 08053 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30204741 | Background | Smith H, Borchard K, Cherian P, Tai Y, Vinciullo C. Randomized Controlled Trial of Preoperative Topical Decolonization to Reduce Surgical Site Infection for Staphylococcus aureus Nasal Swab-Negative Mohs Micrographic Surgery Patients. Dermatol Surg. 2019 Feb;45(2):229-233. doi: 10.1097/DSS.0000000000001662. | |
| 24090258 | Background |
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We have not decided whether or not individual participant data (IPD) will be shared, however, if we do, only IPD used in the results publication will be included.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2024 | Jul 29, 2025 |
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| OTHER |
| The Cleveland Clinic | OTHER |
| University of Georgia | OTHER |
| St. Luke's Hospital and Health Network, Pennsylvania | OTHER |
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| Mupirocin 2% Ointment | Drug | Mupirocin 2% ointment will be applied to the inside of the nostrils twice daily, in the morning and evening, for 5 days prior to surgery. A small amount of the ointment will be placed on the tip of a cotton swab to facilitate application to each nostril. |
|
| Cherian P, Gunson T, Borchard K, Tai Y, Smith H, Vinciullo C. Oral antibiotics versus topical decolonization to prevent surgical site infection after Mohs micrographic surgery--a randomized, controlled trial. Dermatol Surg. 2013 Oct;39(10):1486-93. doi: 10.1111/dsu.12318. |
| 31415257 | Background | Molina GE, Yu SH, Neel VA. Observations Regarding Infection Risk in Lower-Extremity Wound Healing by Second Intention. Dermatol Surg. 2020 Oct;46(10):1342-1344. doi: 10.1097/DSS.0000000000002094. No abstract available. |
| 16792648 | Background | Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x. |
| 29136259 | Background | Liu X, Sprengers M, Nelemans PJ, Mosterd K, Kelleners-Smeets NWJ. Risk Factors for Surgical Site Infections in Dermatological Surgery. Acta Derm Venereol. 2018 Feb 7;98(2):246-250. doi: 10.2340/00015555-2844. |
| 32483093 | Background | Schimmel J, Belcher M, Vieira C, Lawrence N, Decker A. Incidence of Surgical Site Infections in Second Intention Healing After Dermatologic Surgery. Dermatol Surg. 2020 Dec;46(12):1492-1497. doi: 10.1097/DSS.0000000000002409. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D016712 | Mupirocin |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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