Actively Recruiting
Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial
Led by Stanford University · Updated on 2026-05-26
72
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on patients with Stage 3 pilonidal disease, a condition affecting the skin near the tailbone. Researchers are comparing two wound cleaning solutions used during surgery to find out which one helps wounds heal faster. The study is randomized and double-blinded to ensure unbiased results and aims to determine the best wound irrigation method for future patients. Participants will be randomly assigned to have their surgical wounds cleaned with either hypochlorous acid solution (Vashe) or the standard saline solution during excision surgery. All other surgical steps remain the same for both groups. After surgery, wound healing progress will be closely monitored with scheduled photographs and clinical assessments. Participants will submit wound photographs on specific postoperative days and then weekly until the wound closes, allowing researchers to track healing time and any complications. Follow-up clinic visits will occur every three months for two years to monitor for disease recurrence. The main measure is the time from surgery to wound closure, with recurrence rates also recorded over the long term.
CONDITIONS
Brief Title
Intraoperative Wound Irrigation for Pilonidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System
You will not qualify if you...
- Patients with pilonidal disease that is not classified as stage 3
- Intellectual disability precluding the patient and/or guardian from being able to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the Pediatric General Surgery Clinic
Duration - 1 day
Participants undergo surgery to excise Stage 3 pilonidal disease, during which the surgical wound is irrigated with either hypochlorous acid solution or normal saline according to randomization.
Surgery day visit (in-person)
Duration - Approximately 2 weeks or until wound closure
Participants send photographs of the surgical site on postoperative days 0, 2, 5, 7, 10, and 14 (± 1 day), then weekly until the wound closes. Study staff review images to monitor wound healing and complications.
Multiple remote photograph submissions plus wound closure monitoring
Duration - 2 years
Participants attend clinic visits every 3 months for 2 years after surgery to assess for recurrence of pilonidal disease at the surgical site.
Clinic visits every 3 months for 2 years (in-person)
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
E
Elena Harnish, MA
E
Elton Ortiz, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here