Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01534858
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2012-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft neo-epithelisation', 'timeFrame': '29 days'}, {'measure': 'Time to complete epithelization', 'timeFrame': '29 days'}, {'measure': 'Wound infection', 'timeFrame': '29 days'}, {'measure': 'Need for re-operation of target wound site', 'timeFrame': '29 days'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '29 days'}, {'measure': 'Pruritis', 'timeFrame': '29 days'}, {'measure': 'Erythema', 'timeFrame': '29 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds'], 'conditions': ['Burns']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/29668985', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the healing of split thickness skin grafts when treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partial of full thickness burns requiring split thickness grafts\n* Target burn wound size 10cm2-1000cm2\n* Age ≥ 18 years\n* Ability to read, write and speak German.\n* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence.\n* Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence).\n\nExclusion Criteria:\n\n* Target wound has exposed hyaline cartilage\n* Connective tissue disorder\n* Previous skin graft failure at target wound site\n* Total burn surface area ≥ 70%\n* Infected target wound\n* Immunosuppression therapy\n* Chronic hemodialysis\n* Steroid use\n* Diabetes (Type I)\n* Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X\n* Allergy or sensitivity to chlorhexidine\n* Pregnancy\n* Simultaneous participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01534858', 'briefTitle': 'A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Ltd. Centre of Excellence Infection Control'}, 'officialTitle': 'A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts', 'orgStudyIdInfo': {'id': 'OPM-O-H-1102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partial and full thickness burns with split thickness grafts', 'interventionNames': ['Device: Prontosan Wound Gel X']}], 'interventions': [{'name': 'Prontosan Wound Gel X', 'type': 'DEVICE', 'otherNames': ['polihexanide and betaine containing hydrogel'], 'description': 'Prontasan Wound Gel X will be applied topically as a thin layer to the entire grafted area immediately after transplant and with each dressing change.', 'armGroupLabels': ['Partial and full thickness burns with split thickness grafts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67071', 'city': 'Ludwigshafen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliche Unfallklinik Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliches Unfallklinikum Bergmannsheil', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinikum St. Georg', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Adrien Daigeler, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum'}, {'name': 'Jurij Kiefer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Berufsgenossenschaftliche Unfallklinik Ludwigshafen'}, {'name': 'Adrian Dragu, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum St. Georg Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Ltd. Centre of Excellence Infection Control', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}