Intraoperative Wound Irrigation for Pilonidal Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypochlorous Acid.
- Who it may be relevant to
- Registry conditions: Pilonidal Disease. Basic parameters: 8 months — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Time to Wound Closure [Time frame: From day of surgery to wound closure at ~14 days]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lucile Packard Children's Hospital - Stanford — Palo Alto
Identifiers
NCT: NCT07417202 · 84430