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/Actively Recruiting
Led by The Cooper Health System · Updated on 2025-08-26
848
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
N
Naomi Lawrence, MD
F
Faria Nusrat, BS
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The Cooper Health System
Lead Sponsor
University of California, Davis
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Chlorhexidine Showers & Mupirocin Ointment | No Preoperative Decolonization |
|---|---|---|
| What it is | Participants perform full-body showers with chlorhexidine 4% solution and apply intranasal mupirocin ointment twice daily for 5 days before skin cancer surgery on the lower extremity. | Participants receive usual care, undergoing skin cancer surgery on the lower extremity without a protocolized preoperative bacterial decolonization regimen. |
| Role in trial | Investigational intervention: evaluated for its ability to reduce the rate of surgical site infections when used before surgery. | Direct comparator arm: receives standard perioperative care, enabling comparison with the decolonization protocol for infection prevention. |
| Primary use | Aims to lower the risk of surgical site infection after lower extremity skin cancer surgery by reducing bacterial colonization prior to the procedure. | Represents usual surgical practice without targeted bacterial decolonization, serving as a baseline to assess infection risk. |
| How it is given or performed | Showering with chlorhexidine soap covers the neck to feet (excluding face and genitalia) for five days before surgery, plus mupirocin ointment is applied to both nostrils twice daily during the same preoperative window. | Participants proceed with surgery as planned without a structured preoperative decolonization protocol. |
| Evidence status | Evidence from randomized studies in dermatologic surgery indicates that targeted topical decolonization lowers the risk of surgical site infection compared to no decolonization, although reduction in low-risk populations may be modest. | Standard care without preoperative decolonization is associated with baseline surgical site infection rates after lower extremity skin cancer surgery, reported between 2% and 7% in observational studies of wounds left to heal by secondary intention. |
| Important limitations | Requires multiple days of extra preoperative steps and may not reduce infection risk further in patients already at low baseline risk. The impact in populations with higher baseline risk or with different wound management strategies may differ. | Infection risk remains present, especially in lower limb surgeries left to heal by secondary intention, and may vary with patient factors like diabetes or wound size. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/16792648/The Cooper Health System
Lead Sponsor
University of California, Davis
Collaborating Sponsor