Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 2:21 AM
Study NCT ID:
NCT05170035
Status:
UNKNOWN
Last Update Posted:
2023-03-16
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded photo assesment of wound healing by two independent trained clinical doctors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blinded assesment of wound healing at day 18-20.', 'timeFrame': 'Day 18-20', 'description': 'Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.'}], 'secondaryOutcomes': [{'measure': 'Blinded assesment of wound healing at day 11-13', 'timeFrame': 'day 11-13', 'description': 'Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.'}, {'measure': 'TEWL measurement', 'timeFrame': 'day 11-13 and day 18-20', 'description': "Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control."}, {'measure': 'Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.', 'timeFrame': '6 months', 'description': 'The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points.'}, {'measure': 'Difference in microbiology between intervention wounds and control wounds.', 'timeFrame': 'day 1 and day 11-13', 'description': 'Swab test for microbiome analysis will be conducted at day 1 and day 11-13.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Cancer', 'Basal Cell Carcinoma', 'Mohs micrographic surgery', 'MMS', 'Autologous patch', 'Secondary intention healing'], 'conditions': ['Skin Cancer', 'Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing\n2. Presenting relevant medical record report at study initiation\n3. Written informed consent obtained from subject\n4. Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.\n\nExclusion Criteria:\n\n1. A subjects with major systemic disease not yet stabilized\n2. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.\n3. Pregnant or breast feeding\n4. Unable to follow the outlined study protocol\n5. Participation in other studies at the same time that may affect the wound healing."}, 'identificationModule': {'nctId': 'NCT05170035', 'briefTitle': 'Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Autologous Patch-project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMS + Autologous patch', 'description': 'Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.', 'interventionNames': ['Procedure: MMS + Autologous patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMS + Secondary intention healing', 'description': 'Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing', 'interventionNames': ['Procedure: MMS and secondary intention healing']}], 'interventions': [{'name': 'MMS + Autologous patch', 'type': 'PROCEDURE', 'description': 'A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.', 'armGroupLabels': ['MMS + Autologous patch']}, {'name': 'MMS and secondary intention healing', 'type': 'PROCEDURE', 'description': 'Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)', 'armGroupLabels': ['MMS + Secondary intention healing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Katrine E Karmisholt, Ph.D.', 'role': 'CONTACT', 'email': 'Katrine.elisabeth.karmisholt@regionh.dk'}, {'name': 'Anna A Harager', 'role': 'CONTACT', 'email': 'Anna.ahm.harager@regionh.dk', 'phone': '+4531333953'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Katrine E Karmisholt, MD, PhD', 'role': 'CONTACT', 'email': 'katrine.elisabeth.karmisholt@regionh.dk', 'phone': '+4561664351'}, {'name': 'Anna A Harager, Bsc', 'role': 'CONTACT', 'email': 'Anna.ahm.harager@regionh.dk', 'phone': '+4531333953'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benzon Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Chief Consultant, Ass.Prof., PhD', 'investigatorFullName': 'Katrine Elisabeth Karmisholt', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}