Clinical trial · Interventional
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgical Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine gluconate (4%) | Drug | — | UNRESOLVED |
| Mupirocin 2% Ointment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- 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.
- interventionNames
- Drug: Chlorhexidine gluconate (4%)
- Drug: Mupirocin 2% Ointment
- type
- NO_INTERVENTION
- label
- Control Group
- description
- This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery.
Primary outcomes (1)
- measure
- Number of Participants with Surgical Site Wound Infection
- timeFrame
- From date of surgery to 1-month post-operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDSmith H, Borchard K, Cherian P, Tai Y, Vinciullo C. Randomized Controlled Trial of Preoperative Topical Decolonization to Reduce Surgical Site Infection for Staphylococcus aureus Nasal Swab-Negative Mohs Micrographic Surgery Patients. Dermatol Surg. 2019 Feb;45(2):229-233. doi: 10.1097/DSS.0000000000001662. PMID 30204741
- BACKGROUNDCherian P, Gunson T, Borchard K, Tai Y, Smith H, Vinciullo C. Oral antibiotics versus topical decolonization to prevent surgical site infection after Mohs micrographic surgery--a randomized, controlled trial. Dermatol Surg. 2013 Oct;39(10):1486-93. doi: 10.1111/dsu.12318. PMID 24090258
- BACKGROUNDMolina GE, Yu SH, Neel VA. Observations Regarding Infection Risk in Lower-Extremity Wound Healing by Second Intention. Dermatol Surg. 2020 Oct;46(10):1342-1344. doi: 10.1097/DSS.0000000000002094. No abstract available. PMID 31415257
- BACKGROUNDDixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x. PMID 16792648
- BACKGROUNDLiu X, Sprengers M, Nelemans PJ, Mosterd K, Kelleners-Smeets NWJ. Risk Factors for Surgical Site Infections in Dermatological Surgery. Acta Derm Venereol. 2018 Feb 7;98(2):246-250. doi: 10.2340/00015555-2844. PMID 29136259
- BACKGROUNDSchimmel J, Belcher M, Vieira C, Lawrence N, Decker A. Incidence of Surgical Site Infections in Second Intention Healing After Dermatologic Surgery. Dermatol Surg. 2020 Dec;46(12):1492-1497. doi: 10.1097/DSS.0000000000002409. PMID 32483093