The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
NCT ID: NCT07142408
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
848 participants
INTERVENTIONAL
2023-03-13
2030-12-31
Brief Summary
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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.
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Detailed Description
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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:
1. Shower with Hibiclens (Chlorhexidine Gluconate Solution 4% w/v) once daily for 5 days prior to the day of surgery
2. Apply 2% mupirocin ointment to the nostrils twice daily for 5 days prior to the day of surgery
3. Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
4. Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
5. If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
Participants randomized to the control group (standard of care) will:
1. NOT apply the topical antibacterials prior to the day of surgery
2. Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
3. Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
4. If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Treatment Group
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.
Chlorhexidine gluconate (4%)
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.
Mupirocin 2% Ointment
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.
Control Group
This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery.
No interventions assigned to this group
Interventions
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Chlorhexidine gluconate (4%)
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.
Mupirocin 2% Ointment
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo surgical treatment for skin cancer on the lower extremities and have no other surgeries scheduled in the coming weeks after the procedure
* Will have a surgical wound that will be left open to heal by secondary intention
Exclusion Criteria
* Have a known allergy to chlorhexidine or mupirocin
* Have a history of Staphylococcus aureus infection
* Have a history of heart valve or joint replacement surgery requiring pre-operative antibiotics
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Washington University School of Medicine
OTHER
Baylor College of Medicine
OTHER
Princeton Healthcare System
OTHER
The Cleveland Clinic
OTHER
University of Georgia
OTHER
St. Luke's Hospital and Health Network, Pennsylvania
OTHER
The Cooper Health System
OTHER
Responsible Party
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Locations
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The Center for Dermatologic Surgery at Cooper University Health Care
Marlton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Cooper IRB Number 21-119
Identifier Type: -
Identifier Source: org_study_id
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