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.
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
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
Parallel
Chlorhexidine gluconate (4%)
DrugChlorhexidine 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
DrugMupirocin 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.
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.
Type of Pathogens Present in Surgical Site
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.
Click on the lead sponsor to view all of their trials.
The Cooper Health System
Lead sponsor
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
