Actively Recruiting
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease With Myriad Extracellular Matrix Implantation
Led by Yosef Nasseri, MD · Updated on 2026-03-27
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
Y
Yosef Nasseri, MD
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pilonidal disease is a long-lasting condition causing painful inflammation and infection near the top of the buttocks, often requiring surgery. This research compares two different wound rinses used before closing the surgical flap in patients with pilonidal disease to see if one can reduce post-surgery infections and wound problems. The study focuses on patients undergoing flap closure along with implantation of an extracellular matrix to support healing. Participants will receive either an antiseptic rinse called Irrisept, containing 0.05% chlorhexidine gluconate, or the standard rinse using sterile normal saline during their flap-based closure surgery. Both treatments are applied during surgery right before the wound is closed, and all other surgical care follows usual practices. The study groups are randomly assigned to compare the effects of these two rinses on surgical outcomes. During the study, participants will be monitored for up to 3 months after surgery to assess wound healing progress and any complications such as infection, fluid buildup, or wound separation. Researchers will track treatment-emergent adverse events and measure time to complete wound healing. This follow-up helps evaluate the safety and effectiveness of the rinse solutions used during surgery.
CONDITIONS
Brief Title
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with the study plan
- Male or female patients aged 18 years or older
- Scheduled for flap-based surgery for pilonidal disease with planned use of Irrisept or normal saline irrigation
- Willing and able to follow all treatment and evaluation schedules
You will not qualify if you...
- Known allergy to Irrisept (chlorhexidine gluconate)
- Full-thickness (third degree) burns
- Wounds with uncontrolled clinical infection (CDC Contamination Grade 4)
- Any medical condition or serious illness that makes participation undesirable
- Participation in another clinical study within 30 days prior to enrollment
- Pregnant or lactating women
- Any subject deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo bilateral gluteal fasciocutaneous flap closure surgery with implantation of the Myriad extracellular matrix. The surgical wound is irrigated with either Irrisept (0.05% chlorhexidine gluconate) or normal saline immediately before closure.
1 surgical visit (in-person)
Duration - Up to 3 months after surgery
Participants are monitored for wound healing progress and any treatment-emergent adverse events, including infection, seroma, hematoma, and wound dehiscence.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Surgery Group LA
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
Y
Yosef Nasseri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here