Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 8:15 AM
Study NCT ID:
NCT06503406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team.', 'timeFrame': 'up to 5 weeks', 'description': 'This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft.'}], 'secondaryOutcomes': [{'measure': 'Clinical incidence of skin substitute infection', 'timeFrame': 'up to 5 weeks', 'description': 'Incidence of infections and inflammatory response and scar development'}, {'measure': 'Days of skin graft application from time of SupraSDRM® or SoC application', 'timeFrame': 'up to 5 weeks', 'description': 'The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly'}, {'measure': 'Percentage graft survival as assessed 7 days after skin graft application', 'timeFrame': '7 days', 'description': 'Percent of graft survival will be measured by clinical assessment'}, {'measure': 'Number of return trips to the OR', 'timeFrame': 'up to 1 year', 'description': 'The wounds will be assessed by their care team as part of standard care procedures. Research personal will document any areas of concern or additional surgeries required.'}, {'measure': 'Skin graft contraction', 'timeFrame': 'up to 1 year', 'description': 'Patient and Observer Scar Assessment Scale (POSAS) Questionnaire will be used to assess scaring and contraction. This scale uses a 1-10 rating scale with 1 being normal and 10 being worst imaginable outcome.'}, {'measure': 'Wound Pain scale 1-10', 'timeFrame': 'up to 1 year', 'description': 'Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'up to 1 year', 'description': 'looking at the overall length of stay in the hospital, the number of trips to the operating room and cost of skin substitute will help determine if the study dressing is more or less cost affective'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Wound', 'Burns', 'Trauma Injury']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.', 'detailedDescription': 'Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age ≥18 years and ≤85 years\n* Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon\n* Wound size ≥ 5cm2 not immediately suitable for graft application\n* Subject or legally authorized representative is able and willing to sign informed consent\n\nExclusion Criteria:\n\n* Study wound may not include areas of the face, and neck and genitalia.\n* Wound with metal hardware exposure\n* Pressure sores\n* Wounds with residual malignancy\n* Wound infection at the time of planned wound dressing application\n* Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit)\n* Pregnancy/lactation\n* Subjects who are unable to follow the protocol or who are likely to be non-compliant\n* Subjects with uncontrolled diabetes (defined by Hgb A1C \\>10)\n* Subjects who are receiving systemic steroids or immune suppressive treatment\n* Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials.\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06503406', 'briefTitle': 'A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds', 'organization': {'class': 'OTHER', 'fullName': 'The Metis Foundation'}, 'officialTitle': 'A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds', 'orgStudyIdInfo': {'id': 'Pro00076270'}, 'secondaryIdInfos': [{'id': 'CDMRP-RC220169', 'type': 'OTHER_GRANT', 'domain': 'Congressionally Directed Medical Research Program'}, {'id': 'E04634.1a', 'type': 'OTHER', 'domain': 'Office of Human and Animal Research Oversight'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SupraSDRM®', 'description': 'Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.', 'interventionNames': ['Device: SupraSDRM®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC Skin Substitute', 'description': 'Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.', 'interventionNames': ['Device: NovoSorb® BTM']}], 'interventions': [{'name': 'SupraSDRM®', 'type': 'DEVICE', 'description': 'SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.', 'armGroupLabels': ['SupraSDRM®']}, {'name': 'NovoSorb® BTM', 'type': 'DEVICE', 'description': 'NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140', 'armGroupLabels': ['SOC Skin Substitute']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Victoria Diaz, RN', 'role': 'CONTACT', 'email': 'Diaz@metisfoundationusa.org', 'phone': '2105691140'}, {'name': 'Kristin Anselmo', 'role': 'CONTACT', 'email': 'kanselmo@metisfoundationusa.org'}], 'overallOfficials': [{'name': 'Rodney Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metis Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Metis Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'The United States Army Institute of Surgical Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}