Pilonidal Sinus Disease Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan

• Male or female patients aged 18 years or above

• Patients scheduled for flap-based procedure for pilonidal disease with planned use of Irrisept or normal saline irrigation

• Subjects who are willing and able to comply with all aspects of the treatment and evaluation schedule

Locations
United States
California
Surgery Group LA
RECRUITING
Los Angeles
Contact Information
Primary
Yosef Nasseri, MD
yosefn@surgerygroupofla.com
310-289-1518
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 60
Treatments
Experimental: Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation
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.
Active_comparator: Arm 2: Normal Saline Irrigation (Standard of Care)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Irrimax Corporation
Leads: Yosef Nasseri, MD

This content was sourced from clinicaltrials.gov