Recruiting
Phase 3

Hibiclens & Mupirocin

Sponsor:

The Cooper Health System

Code:

NCT07142408

Conditions

Surgical Wound Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chlorhexidine gluconate (4%)

Mupirocin 2% Ointment

Study Details

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

Study ID

NCT07142408

Start date

Mar 13, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

848 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Control Group

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

Interventions

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.

Primary outcome measure

  • Number of Participants with Surgical Site Wound Infection [ Time Frame: From date of surgery to 1-month post-operation ]

Central Contacts and Locations

Locations

The Center for Dermatologic Surgery at Cooper University Health Care

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Principal Investigator:

Naomi Lawrence, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2025-08-26.