Intraoperative Wound Irrigation for Pilonidal Disease

Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Disease
• Intervention / Treatment: Procedure: Hypochlorous Acid

Detailed Description

This study will evaluate whether irrigating the surgical wound with hypochlorous acid solution (Vashe, Urgo Medical) during excision of Stage 3 pilonidal disease leads to faster wound closure compared with normal saline irrigation. The goal is to identify which intraoperative irrigation solution produces better healing outcomes and could be adopted as the preferred standard approach for future patients.

Patients who present to the Pediatric General Surgery Clinic at Stanford with pilonidal disease complaints will be screened for potential enrollment by the principal investigator and clinic provider. During the clinic visit, the study will be explained to the patient and their guardian(s). A retrospective review of the medical record to collect demographic information, prior treatment history, and disease severity will be conducted to confirm eligibility.

On the day of surgery, participants will be prospectively randomized using a pre-specified allocation sequence to one of two intraoperative wound irrigation groups: normal saline or Vashe (hypochlorous acid). During the operation, the surgeon will irrigate the post-excision wound with the solution assigned by randomization. All other aspects of the surgical procedure will follow standard clinical protocols.

After surgery, participants will be monitored for wound healing using photographs of the surgical site. Photographs will be requested on postoperative days 0, 2, 5, 7, 10, and 14 (± 1 day), and then weekly until the wound is closed. Study personnel will review submitted images to track wound healing over time, document any complications, and determine the time to wound closure. Recurrence of pilonidal disease at the original surgical site will be assessed by clinical examination in the clinic at 3-month intervals for 2 years after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elton Ortiz, MS; Phone Number: 650-723-6439; Email: elton@stanford.edu
• Study Contact Backup: Name: Elena Harnish, MA; Phone Number: 650-739-6427; Email: eharnish@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucile Packard Children's Hospital - Stanford
      • Contact: Elena Harnish, MA; Phone Number: 650-739-6427; Email: eharnish@stanford.edu
      • Contact: Bill Chiu, MD; Phone Number: 650-723-6439; Email: bhsc@stanford.edu
      • Principal Investigator: Bill Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vashe; Participants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively.	Procedure: 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.
No Intervention: Saline; Participants randomized to this arm will have a saline solution used for wound irrigation, which is the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Disease	Assessment of whether disease has recurred throughout the duration of long-term follow-up over the 2 year study period.	Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Bill Chiu, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pilonidal disease; pilonidal cyst; pilonidal excision
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus; Inorganic Chemicals; Chlorine Compounds; Oxides; Oxygen Compounds; Acids, Noncarboxylic; Acids; Reactive Oxygen Species; Free Radicals; Hypochlorous Acid
• Other Study ID Numbers: 84430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes