Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-27 @ 4:31 AM
Study NCT ID:
NCT05837403
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}], 'ancestors': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing of fissure', 'timeFrame': '3 months', 'description': 'Complete epithelization of fissure base'}], 'secondaryOutcomes': [{'measure': 'Duration of pain', 'timeFrame': '3 months', 'description': 'Duration of pain after passing bowel motion measured in minutes'}, {'measure': 'Pain change', 'timeFrame': '3 months', 'description': 'Visual analog scale for measuring the intensity of pain (the higher score means the more severe the pain) explained as 0 represent no pain at all, and 10 represent the severest pain ever felt.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fissure in Ano', 'Platelet-Rich Plasma', 'Lateral Internal Sphincterotomy'], 'conditions': ['Fissure in Ano']}, 'descriptionModule': {'briefSummary': 'use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.', 'detailedDescription': 'Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.\n\nThe mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).\n\nThe four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• chronic anal fissure for more than three months\n\nExclusion Criteria:\n\n* medical comorbidity\n* inflammatory bowel disease\n* tuberculosis fissure\n* HIV infected patients'}, 'identificationModule': {'nctId': 'NCT05837403', 'briefTitle': 'The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure', 'organization': {'class': 'OTHER', 'fullName': 'Al-Kindy College of Medicine'}, 'officialTitle': 'The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure', 'orgStudyIdInfo': {'id': '14 Al-KindyCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitroglycerin only', 'description': 'application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.', 'interventionNames': ['Drug: Nitroglycerin ointment']}, {'type': 'EXPERIMENTAL', 'label': 'platelet rich plasma injection', 'description': 'injection of platelet rich plasma under fissure base and edges', 'interventionNames': ['Procedure: Platelet rich plasma injection', 'Drug: Nitroglycerin ointment']}], 'interventions': [{'name': 'Platelet rich plasma injection', 'type': 'PROCEDURE', 'description': 'venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.', 'armGroupLabels': ['platelet rich plasma injection']}, {'name': 'Nitroglycerin ointment', 'type': 'DRUG', 'otherNames': ['Rectocare - Ointment'], 'description': 'application of the ointment twice daily', 'armGroupLabels': ['Nitroglycerin only', 'platelet rich plasma injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10011', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Al-Kindy Teaching Hospital', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Taghreed Alhaidari, C.A.B.O.G', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Kindy College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Kindy College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}