NCT07321704

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yosef Nasseri, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pilonidal sinus disease (PSD) is an acquired condition involving chronic inflammation and infection in the sacrococcygeal region. Over time, PSD can lead to recurrent infections, draining tracts, abscess formation, and the need for repeated procedures. Surgical management often includes flap-based closure techniques. The bilateral gluteal fasciocutaneous flap with midline closure, combined with implantation of an extracellular matrix, is designed to provide durable coverage and improve wound healing. However, wound-related complications remain common. Reported rates of wound dehiscence for flap-based closures range from approximately 10% to 36%, and infection and seroma formation continue to be major concerns. This prospective study evaluates whether the use of Irrisept (0.05% chlorhexidine gluconate) as an antimicrobial irrigation solution during flap closure can reduce these complications compared with standard irrigation using normal saline. The study will assess safety and effectiveness by comparing the rates of postoperative infection, seroma, hematoma, wound dehiscence, and time to complete wound healing between the two groups. Participants will be adults undergoing bilateral gluteal fasciocutaneous flap closure with implantation of the Myriad extracellular matrix for treatment of pilonidal disease. All other aspects of surgical care will follow standard practice. Participants will be monitored after surgery for healing progress and any treatment-emergent adverse events.

Conditions

• Pilonidal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-17
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2026-01-07
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study