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

NCT ID: NCT07321704

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-12
• Study Completion Date: 2027-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Irrisept (0.05% chlorhexidine gluconate)

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Chlorhexidine gluconate wound lavage; CHG 0.05% irrigation; Sterile saline; standard irrigation

Eligibility Criteria

Inclusion Criteria

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

2. Male or female patients aged 18 years or above

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

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

Exclusion Criteria

1. Known allergy to contents of Irrisept (chlorhexidine gluconate)

2. Full-thickness ('third degree') burns

3. Wounds with uncontrolled clinical infection (CDC Contamination Grade 4)

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

5. Currently participating or has participated in another clinical study within 30 days prior to enrollment

6. Pregnant or lactating women

7. Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: collaborator

Yosef Nasseri, MD

OTHER

Sponsor Role: lead

Responsible Party

Yosef Nasseri, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Surgery Group LA

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yosef Nasseri, MD

Role: CONTACT

yosefn@surgerygroupofla.com

310-289-1518

Facility Contacts

Yosef Nasseri, MD

Role: primary

310-289-1518

Other Identifiers

Pro00091579

Identifier Type: -

Identifier Source: org_study_id