Pilonidal DiseaseNCT07321704
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease
A study testing Irrisept (0.05% chlorhexidine gluconate) and Normal Saline in people with Pilonidal Disease, run by Yosef Nasseri, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Irrisept (0.05% chlorhexidine gluconate) and Normal Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Surgery Group LA
Los Angeles, California, 90048
Yosef Nasseri, MD, 310-289-1518
Yosef Nasseri, MD
About this study
Official title: 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
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.
Read the 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
- Being tested
- Irrisept (0.05% chlorhexidine gluconate), Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisept (0.05% chlorhexidine gluconate)Device
Also called Chlorhexidine gluconate wound lavage, CHG 0.05% irrigation
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 SalineOther
Also called Sterile saline, standard irrigation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of surgery through 3-month postoperative follow-up
Secondary outcomes (4)
Time to Complete Wound Healing
Number of weeks from surgery to complete wound healing, defined as full epithelialization without drainage, dehiscence, or need for additional wound treatment.
Measured: Up to 3 months after surgery
Postoperative Infection Rate
Proportion of participants who develop a postoperative surgical site infection, defined by clinical assessment as purulent drainage, positive wound culture, or physician diagnosis requiring antibiotics or procedural intervention.
Measured: Up to 3 months after surgery
Seroma or Hematoma Formation
Proportion of participants who develop a postoperative seroma or hematoma confirmed by clinical exam or imaging and requiring observation or intervention.
Measured: Up to 3 months after surgery
Wound Dehiscence
Proportion of participants who experience wound separation (partial or complete) requiring additional wound care, packing, or procedural management.
Measured: Up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start17 Feb 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yosef Nasseri, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor-investigator, Yosef Nasseri, MD, Nasseri,Yosef MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321704
- Sponsor's protocol ID
- Pro00091579
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07321704
- Acronym / sponsor ID
- Pro00091579
- Conditions
- Pilonidal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yosef Nasseri, MDUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation | Experimental | Device: Irrisept (0.05% chlorhexidine gluconate)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. |
| Arm 2: Normal Saline Irrigation (Standard of Care) | Active comparator | Other: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrisept (0.05% chlorhexidine gluconate)Also: Chlorhexidine gluconate wound lavage, CHG 0.05% irrigationIrrisept 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. | Device | Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation |
| Normal SalineAlso: Sterile saline, standard irrigationSterile 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. | Other | Arm 2: Normal Saline Irrigation (Standard of Care) |
Primary outcome
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.
4 secondary outcomes
Time to Complete Wound Healing
Time frame: Up to 3 months after surgery
Postoperative Infection Rate
Time frame: Up to 3 months after surgery
Seroma or Hematoma Formation
Time frame: Up to 3 months after surgery
Wound Dehiscence
Time frame: Up to 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept (0.05% chlorhexidine gluconate) and Normal Saline in people with Pilonidal Disease, run by Yosef Nasseri, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yosef Nasseri, MD (310-289-1518, yosefn@surgerygroupofla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (TEAEs) (time frame: From the day of surgery through 3-month postoperative follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.