Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 9:35 AM
Study NCT ID:
NCT07417202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Wound Irrigation for Pilonidal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}], 'ancestors': [{'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Wound Closure', 'timeFrame': 'From day of surgery to wound closure at ~14 days', 'description': 'The primary outcome is the length of time (in days) that it takes the wound to close following surgery for pilonidal disease.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of Disease', 'timeFrame': 'Wound closure at ~14 days to time of event up to 2 years post-operation, measured at 3-month intervals', 'description': 'Assessment of whether disease has recurred throughout the duration of long-term follow-up over the 2 year study period.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pilonidal cyst', 'pilonidal disease', 'pilonidal excision'], 'conditions': ['Pilonidal Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.\n\nOn 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '8 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System\n\nExclusion Criteria:\n\n* Patients with pilonidal disease that is not classified as stage 3\n* Intellectual disability precluding the patient and/or guardian from being able to consent'}, 'identificationModule': {'nctId': 'NCT07417202', 'briefTitle': 'Intraoperative Wound Irrigation for Pilonidal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '84430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vashe', 'description': 'Participants in this arm will have a hypochlorous acid solution used for wound irrigation intraoperatively.', 'interventionNames': ['Procedure: Hypochlorous Acid']}, {'type': 'NO_INTERVENTION', 'label': 'Saline', 'description': 'Participants randomized to this arm will have a saline solution used for wound irrigation, which is the current standard of care.'}], 'interventions': [{'name': 'Hypochlorous Acid', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Vashe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Bill Chiu, MD', 'role': 'CONTACT', 'email': 'bhsc@stanford.edu', 'phone': '650-723-6439'}, {'name': 'Elena Harnish, MA', 'role': 'CONTACT', 'email': 'eharnish@stanford.edu', 'phone': '650-739-6427'}, {'name': 'Bill Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Lucile Packard Children's Hospital - Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Elena Harnish, MA', 'role': 'CONTACT', 'email': 'eharnish@stanford.edu', 'phone': '650-739-6427'}, {'name': 'Elton Ortiz, MS', 'role': 'CONTACT', 'email': 'elton@stanford.edu', 'phone': '650-723-6439'}], 'overallOfficials': [{'name': 'Bill Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Bill Chiu, MD', 'investigatorAffiliation': 'Stanford University'}}}}