Actively Recruiting
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease
Led by Yosef Nasseri, MD · Updated on 2026-03-27
60
Participants Needed
1
Research Sites
93 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 chronic condition that causes painful inflammation and infection near the top of the buttocks. Many patients require surgery, and one commonly used approach is a bilateral gluteal fasciocutaneous flap with midline closure along with placement of an extracellular matrix to support wound healing. Although effective, this surgery can still lead to wound problems such as infection, fluid collection (seroma), wound separation (dehiscence), and delayed healing. This study aims to compare two different solutions used to rinse the surgical wound before closing it. One solution is Irrisept, which contains 0.05% chlorhexidine gluconate, an antiseptic designed to reduce bacteria. The other is normal saline, which is the current standard rinse used in surgery. The goal is to determine whether using Irrisept can safely reduce post-operative infections and wound-related complications in patients undergoing flap closure and extracellular matrix implantation for pilonidal disease.
CONDITIONS
Official 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 requirements
- Male or female patients aged 18 years or older
- Scheduled for flap-based procedure 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 chlorhexidine gluconate or Irrisept contents
- Full-thickness (third degree) burns
- Wounds with uncontrolled clinical infection (CDC Contamination Grade 4)
- Any serious medical condition or illness making participation undesirable according to investigator
- Participation in another clinical study within 30 days prior to enrollment
- Pregnant or lactating women
- Any subject deemed unsuitable for study inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Surgery Group LA
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
Y
Yosef Nasseri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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