Chlorhexidine (Irrisept) versus normal saline rinse for flap closure in pilonidal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing bilateral gluteal fasciocutaneous flap closure with implantation of an extracellular matrix for pilonidal disease will receive wound irrigation with either Irrisept (0.05% chlorhexidine gluconate) or standard normal saline prior to surgical closure. The study prospectively compares post-operative outcomes including infection, seroma, hematoma, wound dehiscence, and time to complete wound healing between the two irrigation groups. Participants will be treated at a single clinical site and followed after surgery for healing progress and any adverse events. Standard perioperative care aside from the assigned irrigation solution will be followed.

Why it matters

Who can join: the full rules

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

Where it's running

• Surgery Group LA
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Yosef Nasseri, MD
• Email: yosefn@surgerygroupofla.com
• Phone: 310-289-1518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wound cleaning during pilonidal surgery: saline vs. hypochlorous acid

  This study tests whether irrigating the surgical wound with hypochlorous acid during pilonidal disease surgery helps wounds heal faster than saline in Stage 3 cases.

  Recruiting Stanford University · Palo Alto, California · NCT07417202

• Laser hair removal to prevent pilonidal disease from coming back in young people with darker skin

  This project will test whether laser hair removal of the buttock crease helps prevent pilonidal disease from returning in teens and young adults with darker skin tones.

  Recruiting Nemours Children's Clinic · Wilmington, Delaware · NCT06406621

• Testing a topical treatment for pilonidal disease

  This study is testing a new cream to see if it can help people with pilonidal disease feel better and reduce their symptoms.

  Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT06286397

• Comparing surgery and hair removal for pilonidal disease treatment

  This study is testing whether people with pilonidal disease can avoid surgery by just keeping up with regular hair removal after their symptoms go away.

  Recruiting Stanford University · Palo Alto, California · NCT05439291

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.