RecruitingNot ApplicableNCT07321704

Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease

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


Sponsor

Yosef Nasseri, MD

Enrollment

60 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Irrisept (0.05% chlorhexidine gluconate) and Normal Saline for people with pilonidal disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIrrisept (0.05% chlorhexidine gluconate)

Irrisept solution will be used to irrigate the surgical wound prior to flap closure. The solution is applied using manufacturer-recommended technique and volume. No other changes to surgical care are made.

OTHERNormal Saline

Sterile normal saline will be used to irrigate the surgical wound prior to flap closure according to the surgeon's standard technique. No antiseptic agents will be added.


Locations(1)

Surgery Group LA

Los Angeles, California, United States

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NCT07321704


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