Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-04-25 @ 11:28 PM
Study NCT ID:
NCT03020420
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2015-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved wound appearance', 'timeFrame': '8 weeks to 6 months', 'description': 'improved wound appearance by surface area measurement'}, {'measure': 'improved wound appearance', 'timeFrame': '8 weeks to 6 months', 'description': 'wound indentation measurement with caliper'}, {'measure': 'improved wound appearance', 'timeFrame': '8 weeks to 6 months', 'description': 'wound bulge measured with caliper'}, {'measure': 'Modified Vancouver Scar Scale', 'timeFrame': '8 weeks to 6 months', 'description': 'a scale of visual assessment of a scar'}, {'measure': 'Manchester Scar Scale', 'timeFrame': '8 weeks to 6 months', 'description': 'A new quantitative scale for clinical scar assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Incisions']}, 'descriptionModule': {'briefSummary': 'This study tries to prove that Cicatricell cream significantly reduces scarring with better wound appearance as compared to no treatment.', 'detailedDescription': 'At 1st post operative follow up visit, surgical incision(s) will be assessed for healing, after the sutures/staples/steri-strips are removed. To be included in the study the incision must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included. The incisions will be divided into two sections, using an imaginary line between top and bottom, or left and right. One side of the imaginary line will have cicatricell cream applied 2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary line will remain untreated. In the case of a bilateral incision, as in bilateral breast mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision and the 2nd incision will be untreated. The incision(s) will be its own control group. At the end of the treatment phase the incision(s) will be assessed again to compare the healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed IRB approved, written informed consent.\n* Patient from 18 to 60 years of age.\n* Patient who recently underwent a surgery involving linear surgical skin incisions of 5cm or more or patients with two exactly symmetrical separate incisions like bilateral inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included.\n\nExclusion Criteria:\n\n* Known skin allergies.'}, 'identificationModule': {'nctId': 'NCT03020420', 'acronym': 'Cicatricell', 'briefTitle': 'Clinical Trial To Study The Anti-scarring Effect Of Cicatricell', 'organization': {'class': 'OTHER', 'fullName': 'University of Toledo'}, 'officialTitle': 'Clinical Trial To Study The Anti-scarring Effect Of Cicatricell', 'orgStudyIdInfo': {'id': 'Cicatricell'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'receive cicatricell cream', 'interventionNames': ['Other: Cicatricell Cream']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'to treatment'}], 'interventions': [{'name': 'Cicatricell Cream', 'type': 'OTHER', 'description': 'Cream to be applied 2 times a day for 8weeks to 6 months', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'UTMC', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toledo Health Science Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}