NCT07142408

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 848 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 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

• Surgical Wound Infection

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2023-03-13
• Primary completion: 2030-10-01
• Completion: 2030-12-01
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study