Irrisept vs Normal Saline for Pilonidal Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with pilonidal disease who are about to have flap-based surgery. Participants must be willing to follow the study plan and use either Irrisept or normal saline as directed during their procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix and receive intraoperative wound irrigation using either Irrisept or normal saline
Follow-up
Participants are monitored for safety and effectiveness, including postoperative infection, wound dehiscence, and time to complete wound healing
What Are the Treatments Tested in This Trial?
Interventions
- Irrisept
Trial Overview
The study compares two solutions used in surgical wound cleaning before closure: Irrisept, which contains an antiseptic called chlorhexidine gluconate, and normal saline, the standard rinse. The aim is to see if Irrisept better prevents post-surgery infections and other wound complications.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants undergoing bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix will receive intraoperative wound irrigation using Irrisept (0.05% chlorhexidine gluconate) according to the surgeon's standard technique. Irrigation is applied immediately before surgical closure.
Participants undergoing bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix will receive intraoperative wound irrigation using sterile normal saline, consistent with current standard surgical practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yosef Nasseri, MD
Lead Sponsor
Irrimax Corporation
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.