Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-11 @ 11:39 AM
Study NCT ID:
NCT05462860
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527789', 'term': 'poly(lactide-co-trimethylenecarbonate-co-epsilon-caprolactone)'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Proof of concept'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for autograft application', 'timeFrame': '21 days', 'description': 'The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.'}], 'secondaryOutcomes': [{'measure': 'Wound infection rate, wound closure of the region', 'timeFrame': '2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart)', 'description': 'Incidence of infections and inflammatory response and scar development'}, {'measure': 'Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).', 'timeFrame': 'Mid (3-9 months) and long term (52 weeks)', 'description': 'Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.'}, {'measure': 'Patient-reported perception of pain based on the Visual Analog Scale', 'timeFrame': 'After initial application (Day 0) and weekly', 'description': 'Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound of Skin', 'Burns']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.', 'detailedDescription': 'We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female ≥18 years and ≤75 years\n* Acute partial thickness burns by friction, contact, scalding from hot liquids and flame\n* TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet\n* TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)\n* Subject is able and willing to sign Informed Consent or via legally authorized representative\n\nExclusion Criteria:\n\n* Study Wound due to electrical, radioactive, or frostbite-related injury\n* Infection of wounds in the study area at admission per Investigator or treating physician discretion\n* Pregnancy/lactation\n* Subjects who are unable to follow the protocol or who are likely to be non-compliant\n* Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study\n* Prisoners\n* Life expectancy less than 6 months\n* Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment'}, 'identificationModule': {'nctId': 'NCT05462860', 'briefTitle': 'Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds', 'organization': {'class': 'OTHER', 'fullName': 'The Metis Foundation'}, 'officialTitle': 'Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds', 'orgStudyIdInfo': {'id': 'Suprathel'}, 'secondaryIdInfos': [{'id': 'CDMRP-MB200024', 'type': 'OTHER_GRANT', 'domain': 'Congressionally Directed Medical Research Program Office'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suprathel® dressing', 'description': "The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use", 'interventionNames': ['Other: Suprathel®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.', 'interventionNames': ['Other: Suprathel®']}], 'interventions': [{'name': 'Suprathel®', 'type': 'OTHER', 'otherNames': ['standard of care'], 'description': 'Application of standard of care dressing.®', 'armGroupLabels': ['Standard of Care', 'Suprathel® dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carter', 'role': 'CONTACT'}, {'name': 'Booker King, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Carolina Jaycee Burn Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Victoria Diaz, RN', 'role': 'CONTACT', 'email': 'Diaz@metisfoundationusa.org', 'phone': '2105691140'}, {'name': 'Kristin Anselmo', 'role': 'CONTACT', 'email': 'Anselmo@metisfoundationusa.org'}], 'overallOfficials': [{'name': 'Rodney Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metis Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Metis Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}