Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-27 @ 9:17 PM
Study NCT ID:
NCT04896359
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2021-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Doses Vitamin C and Tissular Repair in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-14', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of linear scars', 'timeFrame': 'initial assessment, two weeks after surgery', 'description': 'Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)'}, {'measure': 'Evaluation of linear scars', 'timeFrame': 'second assessment, one month after surgery', 'description': 'Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)'}, {'measure': 'Evaluation of linear scars', 'timeFrame': 'third assessment, three months after surgery', 'description': 'Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tissue Damage']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomize, double-blind, and placebo-controlled study to evaluate in patients with clinical criteria for any of the following open surgical procedure: (1) cesarean section; (2) aesthetic surgery like abdominoplasty; (3) orthopedic surgery; and (4) abdominal open surgery \\[excluding laparoscopic procedures\\] will be invited to receive either a high dose of vitamin C (12.5 g) three times (48 h pre-surgery, immediately before surgery and 48 h post-surgery) or its placebo, to evaluate the tissue repair process using an international validated instrument named Patient and Observer Scar Assessment Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years.\n* Susceptible for any of the following surgical procedures: (1) cesarean section; (2) aesthetic abdominal plastic surgery; (3) orthopedic prosthetic replacement surgery\n* Voluntary consent to participate\n\nExclusion Criteria:\n\n* Known allergy to the vitamin C\n* Known problems with wounds healing\n* Kidney disease (including lithiasis) or gout'}, 'identificationModule': {'nctId': 'NCT04896359', 'briefTitle': 'High Doses Vitamin C and Tissular Repair in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Francisco de Quito'}, 'officialTitle': 'Effect of High Doses of Vitamin C on the Tissular Reparation (Healing) in Patients Under Surgery in the "Hospital de Los Valles".', 'orgStudyIdInfo': {'id': 'HUBI - 14539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'i.v. infusion of 12.5 g vitamin C 48 h before surgery, immediately before surgery, and 48 h after surgery', 'interventionNames': ['Dietary Supplement: Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'i.v. infusion of placebo 48 h before surgery, immediately before surgery, and 48 h after surgery', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': '12.5 grams of ascorbic acid', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'vehicle', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quito', 'state': 'Pichincha', 'country': 'Ecuador', 'facility': 'Hospital de los Valles', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}], 'overallOfficials': [{'name': 'Enrique Teran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad San Francisco de Quito'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Francisco de Quito', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomolec Pharma', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enrique Teran', 'investigatorAffiliation': 'Universidad San Francisco de Quito'}}}}