Reducing skin and nose bacteria before skin cancer surgery to prevent infection in lower leg wounds left to heal
The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention
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 |
| Enrollment | 848 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cooper Health System Academic / other |
| Locations | 1 site (Marlton, New Jersey) |
| Trial ID | NCT07142408 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marlton, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.