NCT07321704 · Yosef Nasseri, MD
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Irrisept (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.
OTHER
Normal 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.
Primary outcome measures
Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the day of surgery through 3-month postoperative follow-up
Proportion of participants who experience any treatment-emergent adverse event following surgery and throughout the follow-up period. Adverse events include any unfavorable or unintended sign, symptom, or medical occurrence temporally associated with the study intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Known allergy to contents of Irrisept (chlorhexidine gluconate)
- Full-thickness ('third degree') burns
- Wounds with uncontrolled clinical infection (CDC Contamination Grade 4)
- Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
- Currently participating or has participated in another clinical study within 30 days prior to enrollment
- Pregnant or lactating women
- Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
Where
- Los Angeles, California
Collaborators
Irrimax Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations