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

NCT07321704 | Recruiting FDA Device

• 1 other identifier: Pro00091579
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• Treatment-Emergent Adverse Events (TEAEs)

  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.

  From the day of surgery through 3-month postoperative follow-up

Secondary Outcomes (4)

• Time to Complete Wound Healing

  Up to 3 months after surgery

• Postoperative Infection Rate

  Up to 3 months after surgery

• Seroma or Hematoma Formation

  Up to 3 months after surgery

• Wound Dehiscence

  Up to 3 months after surgery

Study Arms (2)

Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation

EXPERIMENTAL

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.

Device: Irrisept (0.05% chlorhexidine gluconate)

Arm 2: Normal Saline Irrigation (Standard of Care)

ACTIVE COMPARATOR

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.

Other: Normal Saline

Interventions

Irrisept (0.05% chlorhexidine gluconate) 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.

Also known as: Chlorhexidine gluconate wound lavage, CHG 0.05% irrigation

Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation

Normal Saline 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.

Also known as: Sterile saline, standard irrigation

Arm 2: Normal Saline Irrigation (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yosef Nasseri, MD: lead
• Irrimax Corporation: collaborator

Study Sites (1)

Surgery Group LA

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Interventions

Therapeutic Irrigation; Saline Solution

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yosef Nasseri, MD

CONTACT

310-289-1518; yosefn@surgerygroupofla.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)