The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal

NCT07142408 | Recruiting Phase 3 FDA Drug

• 1 other identifier: Cooper IRB Number 21-119
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Wound Infection

Keywords

Lower Extremity Wound; Skin Cancer Surgery; Infection Rate; Prophylactic Topical Antibiotics; Chlorhexidine; Mupirocin; Wound Healing; Secondary Intention; Infection Prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Type of Pathogens Present in Surgical Site

  From date of surgery to 1-month post-operation

Study Arms (2)

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.

Drug: Chlorhexidine gluconate (4%); Drug: Mupirocin 2% Ointment

Control Group

NO INTERVENTION

This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery.

Interventions

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.

Also known as: Hibiclens

Treatment Group

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years old
• 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

You may not qualify if:

• Age under 18 years old
• 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

Sponsors & Collaborators

• The Cooper Health System: lead
• University of California, Davis: collaborator
• Washington University School of Medicine: collaborator
• Baylor College of Medicine: collaborator
• Princeton Healthcare System: collaborator
• The Cleveland Clinic: collaborator
• University of Georgia: collaborator
• St. Luke's Hospital and Health Network, Pennsylvania: collaborator

Study Sites (1)

The Center for Dermatologic Surgery at Cooper University Health Care

Marlton, New Jersey, 08053, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 30204741 BACKGROUND

• 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.

  PMID: 24090258 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.

  PMID: 31415257 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.

  PMID: 16792648 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.

  PMID: 29136259 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.

  PMID: 32483093 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; Mupirocin; Ointments

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Naomi Lawrence, MD

CONTACT

(856) 596-3040; lawrence-naomi@cooperhealth.edu

Faria Nusrat, BS

CONTACT

(856) 596-3040; nusrat-faria@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 26, 2025
• Study Start: March 13, 2023
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)