Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05149118
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2021-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of PDRN in Post-operative Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011089', 'term': 'Polydeoxyribonucleotides'}], 'ancestors': [{'id': 'D011119', 'term': 'Polynucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up', 'timeFrame': 'at 3 months', 'description': 'modified Vancouver Scar Scale (0 normal skin\\~15 worst)'}], 'secondaryOutcomes': [{'measure': 'Subjective symptoms at the 3-month follow-up', 'timeFrame': 'at 3 months', 'description': 'Pain and itching were assessed using a visual analog scale (VAS) ranged from 0 (no) to 10 (worst).'}, {'measure': 'Erythema and pigmentation at the 3-month follow-up', 'timeFrame': 'at 3 months', 'description': 'Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)'}, {'measure': 'Scar Height (mm) at the 3-month follow-up', 'timeFrame': 'at 3 months', 'description': '3D images of the scars were acquired with an Antera 3D® camera (Miravex Limited, Dublin, Ireland)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital\n\nExclusion Criteria:\n\n* age younger than 20 years or older than 60 years\n* history of keloid development\n* requirement for modified radical neck dissection\n* previous neck surgery\n* current pregnancy or breast feeding\n* allergy to PDRN\n* taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants\n* uncontrolled medical diseases'}, 'identificationModule': {'nctId': 'NCT05149118', 'briefTitle': 'Effect of PDRN in Post-operative Scars', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'B-1811-507-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDRN injected group', 'description': 'The participants in treatment group had received two consecutive injections of PDRN one day and two days after the surgery. A total 1mL of PDRN was injected along the suture line at distance of 1cm in each session.', 'interventionNames': ['Procedure: Polydeoxyribonucleotide (PDRN)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The participants in control group were left untreated.'}], 'interventions': [{'name': 'Polydeoxyribonucleotide (PDRN)', 'type': 'PROCEDURE', 'description': 'A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.', 'armGroupLabels': ['PDRN injected group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Jung Won Shin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jung-Won Shin', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}