Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-05 @ 5:04 AM
Study NCT ID:
NCT02417818
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cutaneous Microcirculation After Plasma Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-04-11', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in microcirculation (composite measure)', 'timeFrame': 'Baseline and 1 minute post-dose', 'description': '* capillary blood flow \\[arbitrary units AU\\]\n* capillary blood velocity \\[AU\\]\n* tissue oxygen saturation \\[%\\]\n* relative postcapillary venous filling pressure \\[AU\\]'}], 'secondaryOutcomes': [{'measure': 'Change in microcirculation (areolar measure)', 'timeFrame': 'Baseline, while and 1 minute post-dose', 'description': '* tissue oxygen saturation \\[%\\]\n* tissue hemoglobin index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Burn Injury', 'Acute Wound', 'Chronic Wound', 'Burn Scar']}, 'referencesModule': {'references': [{'pmid': '36326797', 'type': 'DERIVED', 'citation': 'Lucius J, Jensen JO, Tasar RR, Schleusser S, Stang FH, Mailander P, Kisch T. Acute Microcirculatory Effects of Remote Ischemic Conditioning in Superficial Partial Thickness Burn Wounds. J Burn Care Res. 2023 Jul 5;44(4):912-917. doi: 10.1093/jbcr/irac166.'}]}, 'descriptionModule': {'briefSummary': 'In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that Plasma Therapy can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.\n\nGroup B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.\n\nGroup C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.\n\nGroup D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.\n\nGroup E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.\n\nGroup F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.\n\nGroup G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.\n\nGroup H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups E-G must be evident. No soft tissue injury must be evident.\n\nGroup I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.\n\nGroup J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.\n\nGroup K (n=20): Consent-capable male and female patients ≥18 years of age received a flap.\n\nGroup L (n=20): Consent-capable male and female patients ≥18 years of age received a flap.\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n* below 18 years of age\n* wounds requiring artificial respiration, since consent for the study participation is unobtainable\n\nExclusion criteria groups A, B, D, E, F, H:\n\n* peripheral arterial occlusive disease\n* vasculitis\n* diabetes mellitus\n* chronic kidney or liver disease\n* cardiac dysfunction\n* arterial hypo- or hypertension\n\nAnamnestic exclusion criteria\n\n* ongoing immunosuppressive or chemotherapy treatment\n* drug abuse\n* systemic skin diseases\n* systemic and local cortisone therapy'}, 'identificationModule': {'nctId': 'NCT02417818', 'briefTitle': 'Cutaneous Microcirculation After Plasma Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds', 'orgStudyIdInfo': {'id': '14-266-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Second-Degree Burn', 'description': 'Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.\n\nIntervention: Plasma Therapy (PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Skin Excision (for Skin Graft)', 'description': 'Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.\n\nIntervention: Plasma Therapy (PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Wound', 'description': 'Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.\n\nIntervention: Plasma Therapy (PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intact Skin', 'description': 'Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident.\n\nIntervention: Plasma Therapy (PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Second-Degree Burn (repetitive)', 'description': 'Group E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Skin Excision (for Skin Graft) (repetitive)', 'description': 'Group F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Wound (repetitive)', 'description': 'Group G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intact Skin (repetitive)', 'description': 'Group H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertrophic burn scar', 'description': 'Group F (n=20): Consent-capable male and female patients ≥18 years of age who suffer from a hypertrophic burn scar.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertrophic burn scar (repetitive)', 'description': 'Group F (n=20): Consent-capable male and female patients ≥18 years of age who suffer from a hypertrophic burn scar.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Flap', 'description': 'Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Plasma Therapy (PlasmaDerm)']}, {'type': 'EXPERIMENTAL', 'label': 'Flap (repetitive)', 'description': 'Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap.\n\nIntervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'interventionNames': ['Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)']}], 'interventions': [{'name': 'Plasma Therapy (PlasmaDerm)', 'type': 'DEVICE', 'description': 'Plasma Therapy (PlasmaDerm)', 'armGroupLabels': ['Chronic Wound', 'Flap', 'Hypertrophic burn scar', 'Intact Skin', 'Second-Degree Burn', 'Skin Excision (for Skin Graft)']}, {'name': 'Repetitive Plasma Therapy (repetitive PlasmaDerm)', 'type': 'DEVICE', 'description': 'Repetitive Plasma Therapy (Repetitive PlasmaDerm)', 'armGroupLabels': ['Chronic Wound (repetitive)', 'Flap (repetitive)', 'Hypertrophic burn scar (repetitive)', 'Intact Skin (repetitive)', 'Second-Degree Burn (repetitive)', 'Skin Excision (for Skin Graft) (repetitive)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University of Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Tobias Kisch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tobias Kisch', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}