Intraoperative Wound Irrigation for Pilonidal Disease

NCT07417202 | Recruiting

• 1 other identifier: 84430
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

pilonidal cyst; pilonidal disease; pilonidal excision

Outcome Measures

Primary Outcomes (1)

• Time to Wound Closure

  The primary outcome is the length of time (in days) that it takes the wound to close following surgery for pilonidal disease.

  From day of surgery to wound closure at ~14 days

Secondary Outcomes (1)

• Recurrence of Disease

  Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals

Study Arms (2)

Vashe

EXPERIMENTAL

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

Procedure: Hypochlorous Acid

Saline

NO INTERVENTION

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

Interventions

Hypochlorous Acid PROCEDURE

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.

Vashe

Eligibility Criteria

• Age: 8 Months - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Hypochlorous Acid

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds

Study Officials

• Bill Chiu, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Harnish, MA

CONTACT

650-739-6427; eharnish@stanford.edu

Elton Ortiz, MS

CONTACT

650-723-6439; elton@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)