Intraoperative Wound Irrigation for Pilonidal Disease
ConditionPilonidal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-30
SponsorStanford University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Hypochlorous Acid
Procedure/SurgeryHypochlorous 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: VasheExperimental treatment 1 intervention
Group B: SalineNo intervention 0 interventions
Trial outcomes
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.
Time frame
From day of surgery to wound closure at ~14 daysSecondary 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.
Time frame
Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervalsSponsors and contacts
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Source ClinicalTrials.gov