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NCT07142408 · ClinicalTrials.gov registry record · Phase 3
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
A Phase 3 study of Surgical Wound Infection, sponsored by The Cooper Health System.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 848
- Enrollment target
- 1
- Study location
NCT07142408: Recruiting Phase 3 study of Surgical Wound Infection, sponsored by The Cooper Health System.
NCT07142408 is a Phase 3 study of Surgical Wound Infection that is actively recruiting participants, run by The Cooper Health System. The registered enrollment target is 848 participants, roughly in line with the 823-participant average among 8 other Surgical Wound Infection trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07142408, a Phase 3 study of Surgical Wound Infection, is actively recruiting participants, sponsored by The Cooper Health System.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 848 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Signs of infection, including erythema, edema, drainage, and delayed healing, will be visually determined by study physicians with photographs of the surgical site collected from study participants. All patients will be followed up with a phone call at 1 month to monitor for any adverse events and additional signs of infection including pain, tenderness, warmth, and foul odor at the surgical site.
Conditions Studied
Interventions
- DRUG Chlorhexidine gluconate (4%)
- DRUG Mupirocin 2% Ointment
Study Locations (1)
New Jersey
- The Center for Dermatologic Surgery at Cooper University Health Care - Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2030-12 |
| Phase | Phase 3 |
What NCT07142408 shows while recruiting
NCT07142408 is an interventional study that assigns participants to a tested intervention. The registered 848 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 823-participant average among 8 other Surgical Wound Infection trials with a reported enrollment target.
The record links to 1 condition, with Surgical Wound Infection appearing as the primary indexed condition, and to 2 interventions - of which Chlorhexidine gluconate (4%) is the first listed.
NCT07142408 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07142408 about?
NCT07142408 is a clinical study titled "The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal". 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 i...
What is the current status of trial NCT07142408?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 2023-03-13. Estimated completion is 2030-12.
What conditions does trial NCT07142408 study?
This clinical trial studies the following conditions: Surgical Wound Infection.
What interventions are being tested in trial NCT07142408?
The interventions under investigation include: Chlorhexidine gluconate (4%) (DRUG), Mupirocin 2% Ointment (DRUG).
Who is sponsoring clinical trial NCT07142408?
This trial is sponsored by The Cooper Health System, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07142408 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07142408's enrollment target sits among peer trials
848 2nd of 8 the highest of 8 other Surgical Wound Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Wound Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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