An interventional study of Hypochlorous Acid in Pilonidal Disease, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 8 Months to 30 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 72 is close to the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
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Exclusion Criteria:
Participants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively.
Procedure: Hypochlorous Acid
Participants randomized to this arm will have a saline solution used for wound irrigation, which is the current standard of care.
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.
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.
Time frame: From day of surgery to wound closure at ~14 days
Recurrence of Disease
Assessment of whether disease has recurred throughout the duration of long-term follow-up over the 2 year study period.
Time frame: Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals
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