Recruiting

Saline vs. Hypochlorous Acid

Sponsor:

Stanford University

Code:

NCT07417202

Conditions

Pilonidal Disease

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Hypochlorous Acid

Study Details

Brief summary:

The purpose of this study is to determine the best method for cleaning wounds during surgery for patients with Stage 3 pilonidal disease. The investigators will compare the standard wound cleaning solution, saline, with a different solution called hypochlorous acid (Vashe, Urgo Medical) to see which one helps wounds heal faster after surgery.

Conditions

Pilonidal Disease

Study ID

NCT07417202

Start date

Mar 1, 2026

Status verified date

May, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System

Exclusion Criteria:

  • Patients with pilonidal disease that is not classified as stage 3
  • Intellectual disability precluding the patient and/or guardian from being able to consent

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vashe

Participants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively.

no intervention: Saline

Participants randomized to this arm will have a saline solution used for wound irrigation, which is the current standard of care.

Interventions

Hypochlorous Acid

Hypochlorous acid will be used as the wound irrigation solution instead of the saline which is currently considered standard. All other aspects of the surgery will be the same across both arms.

Primary outcome measure

  • Time to Wound Closure [ Time Frame: From day of surgery to wound closure at ~14 days ]

Central Contacts and Locations

Central contacts

Elena Harnish, MA

650-739-6427eharnish@stanford.edu

Elton Ortiz, MS

650-723-6439elton@stanford.edu

Locations

Lucile Packard Children's Hospital - Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Bill Chiu, MD

650-723-6439bhsc@stanford.edu

Elena Harnish, MA

650-739-6427eharnish@stanford.edu

Principal Investigator:

Bill Chiu, MD

More Information

Sponsor

Stanford University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • pilonidal cyst
  • pilonidal disease
  • pilonidal excision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-26.