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

Conditions

• Surgical Wound Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chlorhexidine gluconate (4%) — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 13, 2023

Status verified

Aug 2025

Primary completion

Oct 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

848 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• Naomi Lawrence, MD
  (856) 596-3040
  [email protected]
• Faria Nusrat, BS
  (856) 596-3040
  [email protected]

Locations (1)

Find similar trials in Marlton, NJ

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