Reducing skin and nose bacteria before skin cancer surgery to prevent infection in lower leg wounds left to heal
Official title: The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention
Run by Cooper Norcross Health · NCT07142408 · Data updated 2026-11-12
This trial will test whether showering with Hibiclens and using mupirocin in the nostrils before surgery lowers infection risk for adults having skin cancer surgery on the lower leg whose wounds are left open to heal.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 848 (estimated) |
| Sponsor | Cooper Norcross Health Academic / other |
| Locations | 1 site (Marlton, New Jersey) |
| Status | Recruiting |
| Started | March 13, 2023 |
| Main results expected | October 2030 |
| Study ends | December 2030 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07142408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are scheduled for skin cancer surgery on the lower leg that will be left open to heal and who do not have allergies to chlorhexidine or mupirocin, no history of Staphylococcus aureus infection, and no prosthetic heart valves or joint replacements requiring preoperative antibiotics are ideal candidates.
✕Probably not a fit
Patients under 18, those allergic to chlorhexidine or mupirocin, those with a prior Staphylococcus aureus infection, or those with prosthetic valves/joints requiring pre-op antibiotics (or who will not have wounds left to heal) are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 randomized trial compares a preoperative decolonization regimen (daily chlorhexidine body wash and twice-daily nasal mupirocin for 5 days) to standard care with no preoperative treatment in adults undergoing skin cancer surgery on the lower extremity with wounds left to heal by secondary intention. Participants in the treatment arm will perform the 5-day regimen before surgery, receive standard wound care after the procedure, and submit wound photos at 2 and 4 weeks with in-person evaluation and wound swab if infection is suspected. The control arm receives usual preoperative care without antibacterial washes or nasal ointment, and outcomes focus on postoperative wound infection rates. Study procedures are conducted at the Cooper University Health Care dermatologic surgery center with collaborators from several academic institutions.
Why it matters
Potential benefit: If successful, the approach could lower post-operative wound infections in lower-leg skin cancer patients, reducing the need for antibiotics, extra clinic visits, and improving healing.
How similar studies have gone: Preoperative skin and nasal decolonization has reduced surgical site infections in some surgical populations (for example orthopedic and cardiac patients), but evidence is limited specifically for open lower-leg skin cancer wounds left to heal by secondary intention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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The Center for Dermatologic Surgery at Cooper University Health Care
Marlton, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Naomi Lawrence, MD
- Email: lawrence-naomi@cooperhealth.edu
- Phone: (856) 596-3040
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.