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Could a simple surgical rinse cut infection risk in pilonidal disease?

NCT ID NCT07321704

Disease control Sponsor: Yosef Nasseri, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two rinses used during surgery for pilonidal disease, a chronic skin condition near the tailbone. One rinse is Irrisept, an antiseptic that kills bacteria, and the other is normal saline, the standard rinse. The goal is to see if Irrisept reduces infections and wound complications after flap closure surgery. About 60 adults having this surgery will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Irrisept (0.05% chlorhexidine gluconate antiseptic solution)
What this could lead to
If it works, this could point toward a simple way to lower infection and wound problems after pilonidal surgery, helping people heal faster.
What could go wrong
This is a small, early-stage trial with only 60 people, so results may not apply to everyone. The antiseptic rinse might not reduce complications more than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pilonidal sinus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pilonidal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Surgery Group LA

    RECRUITING

    Los Angeles, California, 90048, United States

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