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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Chlorhexidine gluconate (4%)
  • Mupirocin 2% Ointment

Treatment groups

848 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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