Recruiting

Irrisept vs. Saline

Sponsor:

Yosef Nasseri, MD

Code:

NCT07321704

Conditions

Pilonidal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irrisept (0.05% chlorhexidine gluconate)

Normal Saline

Study Details

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

Study ID

NCT07321704

Start date

Feb 17, 2026

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

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 measure

  • Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the day of surgery through 3-month postoperative follow-up ]

Central Contacts and Locations

Central contacts

Yosef Nasseri, MD

310-289-1518yosefn@surgerygroupofla.com

Locations

Surgery Group LA

Recruiting

Los Angeles, California, United States, 90048

Contacts

Yosef Nasseri, MD

310-289-1518

Principal Investigator:

Yosef Nasseri, MD

More Information

Sponsor

Yosef Nasseri, MD

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yosef Nasseri, MD on 2026-03-27.