Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07142408

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

Led by The Cooper Health System · Updated on 2025-08-26

848

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

T

The Cooper Health System

Lead Sponsor

U

University of California, Davis

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to find out if using antibacterial soap and ointment before surgery can reduce infections in open wounds on the lower legs of adults having skin cancer surgery. The study compares a group using Hibiclens skin cleanser and mupirocin ointment before surgery to a group receiving usual care without these treatments. It focuses on whether these topical antibiotics lower the chance of wound infections after surgery. Participants in the treatment group will shower daily with Hibiclens for five days before surgery and apply mupirocin ointment inside their nostrils twice daily for the same period. Both groups will have their skin cancer surgery and receive standard wound care instructions. The treatment group uses the antibacterial products before surgery; the control group does not. After surgery, both groups will send photos of their surgical wounds at two and four weeks to check for infections. During the study, researchers will monitor wound healing and infection signs based on the photos and follow-up visits if infection is suspected. They will collect data on the number of infections up to one month after surgery and identify the types of bacteria involved. The study participation involves pre-surgery treatment for some, surgery with wound care, photo submissions for monitoring, and occasional office visits if infection concerns arise.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years old
  • Scheduled to undergo surgical treatment for skin cancer on the lower extremities
  • No other surgeries planned in the weeks following the procedure
  • Will have a surgical wound left open to heal by secondary intention
Not Eligible

You will not qualify if you...

  • Age under 18 years old
  • Known allergy to chlorhexidine or mupirocin
  • History of Staphylococcus aureus infection
  • History of heart valve or joint replacement surgery requiring pre-operative antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 5 days

Participants in the treatment group apply topical antibacterial soap once daily and mupirocin ointment twice daily for 5 days prior to surgery. Participants in the control group do not apply any pre-operative antibacterials.

Daily self-application at home

Surgery

Duration - 1 day

Participants come into the office for their skin cancer surgery on the lower leg. Standard wound care instructions are provided for daily wound management.

1 visit (in-person)

Post-operative Follow-up

Duration - 4 weeks

Participants send pictures of their surgical site at 2 weeks and 4 weeks post-operation to monitor for signs of infection. If infection is suspected, participants return to the office for wound swabbing to determine the cause.

2 remote photo submissions and 1 to 2 in-person visits if infection is suspected

Trial Site Locations

Total: 1 location

1

The Center for Dermatologic Surgery at Cooper University Health Care

Marlton, New Jersey, United States, 08053

Actively Recruiting

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Research Team

N

Naomi Lawrence, MD

F

Faria Nusrat, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Randomized Controlled Trial of Preoperative Topical Decolonization to Reduce Surgical Site Infection for Staphylococcus aureus Nasal Swab-Negative Mohs Micrographic Surgery Patients.

Harvey Smith, Kate Borchard, Paul Cherian...

https://pubmed.ncbi.nlm.nih.gov/30204741

Oral antibiotics versus topical decolonization to prevent surgical site infection after Mohs micrographic surgery--a randomized, controlled trial.

Paul Cherian, Todd Gunson, Kate Borchard...

https://pubmed.ncbi.nlm.nih.gov/24090258