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NCT Number: NCT07142408

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Center for Dermatologic Surgery at Cooper University Health Care

Marlton, New Jersey, 08053, United States

Location status: Recruiting

Location contact

Faria Nusrat, BS

CONTACT

[email protected]

(856) 596-3040

Faria Nusrat, BS

SUB_INVESTIGATOR

Kyle Lauck, MD

SUB_INVESTIGATOR

Naomi Lawrence, MD

CONTACT

[email protected]

856-596-3040

Naomi Lawrence, MD

PRINCIPAL_INVESTIGATOR

Tara Jennings, MD

SUB_INVESTIGATOR

About this study

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:

  • Shower with Hibiclens (Chlorhexidine Gluconate Solution 4% w/v) once daily for 5 days prior to the day of surgery
  • Apply 2% mupirocin ointment to the nostrils twice daily for 5 days prior to the day of surgery
  • 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.
  • 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.
  • 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:

  • NOT apply the topical antibacterials prior to the day of surgery
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Hibiclens

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.

Primary outcomes

  1. Number of Participants with Surgical Site Wound Infection

    Time frame: From date of surgery to 1-month post-operation

    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.

Secondary outcomes

  1. Type of Pathogens Present in Surgical Site

    Time frame: From date of surgery to 1-month post-operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Faria Nusrat, BS

CONTACT

[email protected]

(856) 596-3040

Naomi Lawrence, MD

CONTACT

[email protected]

(856) 596-3040

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Collaborators

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

Registry information

Official study title

The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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