Pilonidal DiseaseNCT07417202
Intraoperative Wound Irrigation for Pilonidal Disease
A study testing Hypochlorous Acid in people with Pilonidal Disease, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 months to 30 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Hypochlorous Acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System
Who cannot join
- Patients with pilonidal disease that is not classified as stage 3
- Intellectual disability precluding the patient and/or guardian from being able to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, 94304
Bill Chiu, MD, 650-723-6439, bhsc@stanford.edu
Elena Harnish, MA, 650-739-6427, eharnish@stanford.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Pilonidal Disease
- Being tested
- Hypochlorous Acid
- Keywords
- pilonidal cyst, pilonidal disease, pilonidal excision
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous AcidProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vashe | Experimental | Participants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of surgery to wound closure at ~14 days
Secondary outcomes (1)
Recurrence of Disease
Assessment of whether disease has recurred throughout the duration of long-term follow-up over the 2 year study period.
Measured: Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Mar 2026
- Primary completionSep 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bill Chiu, MD, Stanford University
- Investigators
- Bill Chiu, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417202
- Sponsor's protocol ID
- 84430
- Status last verified
- May 2026
- First submitted
- 10 Feb 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07417202
- Acronym / sponsor ID
- 84430
- Conditions
- Pilonidal Disease
- Keywords
- pilonidal cyst, pilonidal disease, pilonidal excision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vashe | Experimental | Procedure: Hypochlorous AcidParticipants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively. |
| Saline | No intervention | –Participants randomized to this arm will have a saline solution used for wound irrigation, which is the current standard of care. |
Who may qualify
- Ages
- 8 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System
Key exclusion criteria (2 listed)
- Patients with pilonidal disease that is not classified as stage 3
- Intellectual disability precluding the patient and/or guardian from being able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypochlorous AcidHypochlorous 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. | Procedure or surgery | Vashe |
Primary outcome
Time to Wound Closure
Time frame: From day of surgery to wound closure at ~14 days
The primary outcome is the length of time (in days) that it takes the wound to close following surgery for pilonidal disease.
1 secondary outcome
Recurrence of Disease
Time frame: Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bill Chiu, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypochlorous Acid in people with Pilonidal Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Harnish, MA (650-739-6427, eharnish@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Wound Closure (time frame: From day of surgery to wound closure at ~14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.