Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT04899466
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in pain level', 'timeFrame': '1, 2, 3 and 4 weeks', 'description': 'Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application'}, {'measure': 'Patient satisfaction', 'timeFrame': '1, 2, 3, 4, 6 weeks and 42 days', 'description': 'Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).'}], 'primaryOutcomes': [{'measure': 'Incidence of complete wound closure', 'timeFrame': '4 weeks', 'description': 'Skin re-epithelialization without drainage or dressing requirements'}], 'secondaryOutcomes': [{'measure': 'Wound Percent Area Reduction (PAR)', 'timeFrame': '2, 4 and 6 weeks', 'description': 'The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.'}, {'measure': 'Mean time of complete wound closure', 'timeFrame': '4 weeks', 'description': 'Skin re-epithelialization without drainage or dressing requirements'}, {'measure': 'Durability of wound closure 2 weeks after complete healing', 'timeFrame': 'Up to 6 weeks', 'description': 'No wound dehiscence'}, {'measure': 'Comparison of time to complete closure between study cases and historic control', 'timeFrame': '4 weeks', 'description': 'Skin re-epithelialization without drainage or dressing requirements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dehiscence Wound']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two).\n\nAn historic matched-control group of 20 patients will be compared retrospectively'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Women that had a laparotomy no more than 3 weeks before accrual.\n* Surgical wound dehiscence that requires a secondary closure.\n* Time from wound dehiscence \\>24 hours and \\<6 days.\n* The open wound includes epidermis, dermis and sub cutaneous fat.\n* The patient can sign an informed consent form.\n\nExclusion Criteria:\n\n* Patients with necrotizing fasciitis\n* Patients with fascial dehiscence\n* Cannot withdraw blood in the required amount (up to 18 mL per week).\n* Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded.\n* Pregnancy\n* Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).'}, 'identificationModule': {'nctId': 'NCT04899466', 'briefTitle': 'Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence', 'organization': {'class': 'INDUSTRY', 'fullName': 'RedDress Ltd.'}, 'officialTitle': 'A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence', 'orgStudyIdInfo': {'id': 'RD008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ActiGraft', 'description': 'Whole blood clot (WBC) gel', 'interventionNames': ['Device: ActiGraft']}], 'interventions': [{'name': 'ActiGraft', 'type': 'DEVICE', 'description': 'Whole blood clot (WBC) gel', 'armGroupLabels': ['ActiGraft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Asia Kaizler', 'role': 'CONTACT', 'email': 'asia.kaizler@clalit.org.il', 'phone': '+972506943426'}, {'name': 'Zvi Klein, Dr. Med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Sharon Sirota', 'role': 'CONTACT', 'email': 'sharon@reddress.co.il', 'phone': '+972545800765'}], 'overallOfficials': [{'name': 'Sharon Sirota', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RedDress Ltd.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon publication', 'ipdSharing': 'YES', 'description': 'The results will be part of several scientific publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RedDress Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}