Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-23 @ 1:09 PM
Study NCT ID:
NCT01988818
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Randomized Study of 2 Different Wound Dressings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blistering', 'timeFrame': '0-6 days', 'description': 'Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).'}], 'secondaryOutcomes': [{'measure': 'wound complications', 'timeFrame': '0-6 days', 'description': 'Other wound complications (i.e. leakage, inflammation, infection)'}, {'measure': 'dressing changes', 'timeFrame': '0-6 days', 'description': 'Number of dressing changes'}, {'measure': 'pain', 'timeFrame': '0-6 days', 'description': 'Pain before, during and after dressing removal (VA scale)'}, {'measure': 'performance and acceptability', 'timeFrame': '0-6 days', 'description': 'Performance and acceptability of the dressing (4 point rating scale)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound dressing', 'silicone', 'standard wound dressing'], 'conditions': ['Hip-surgery', 'Knee-surgery', 'Spinal-surgery']}, 'referencesModule': {'references': [{'pmid': '29669676', 'type': 'DERIVED', 'citation': 'Bredow J, Hoffmann K, Oppermann J, Hellmich M, Eysel P, Zarghooni K. Evaluation of Absorbent Versus Conventional Wound Dressing. Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.'}, {'pmid': '25873529', 'type': 'DERIVED', 'citation': 'Bredow J, Oppermann J, Hoffmann K, Hellmich M, Wenk B, Simons M, Eysel P, Zarghooni K. Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:81. doi: 10.1186/s13063-015-0599-z.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:\n\n* the performance of the dressing\n* the comfort, conformability and the acceptability of the dressing\n* pain before, during and after dressing removal\n* the overall cost regarding dressing wear time, time to do dressing change and personal resources needed', 'detailedDescription': 'A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.\n\nMale or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up).\n\nTwo hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).\n\nAEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.\n\nOutcome Measures\n\nPrimary variable:\n\n• Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).\n\nSecondary variables:\n\n* Other wound complications (i.e. leakage, inflammation, infection)\n* Number of dressing changes\n* Pain before, during and after dressing removal (VA scale)\n* Performance and acceptability of the dressing (4 point rating scale)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18years\n2. Have an expected total length of stay of 4 or more days\n3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery\n4. Undergoing hip surgery with a standard access\n5. Give their written informed consent to participate\n\nExclusion Criteria:\n\n1. Dressing size does not fit the incision area\n2. Known allergy/hypersensitivity to any of the components of the dressing\n3. Multi-trauma\n4. Undergoing arthroplasty or spine surgery due to tumour or infection?\n5. Fractures\n6. Wound at the surgical site prior to surgery\n7. Neurological deficit of operated side (hemiplegia, etc.)\n8. Subject has documented skin disease at time of enrolment, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01988818', 'acronym': 'Close', 'briefTitle': 'Prospective, Randomized Study of 2 Different Wound Dressings', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)', 'orgStudyIdInfo': {'id': 'Uni-Köln_2013-02'}, 'secondaryIdInfos': [{'id': 'University Hospital Cologne', 'type': 'OTHER', 'domain': 'University Hospital Cologne'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard wound dressing', 'description': 'As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery', 'interventionNames': ['Device: standard wound dressing']}, {'type': 'EXPERIMENTAL', 'label': 'Mepilex® Border Post-Op', 'description': 'wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing', 'interventionNames': ['Device: Mepilex® Border Post-Op']}], 'interventions': [{'name': 'Mepilex® Border Post-Op', 'type': 'DEVICE', 'otherNames': ['Mepilex® Border Post-Op with Safetac®Technology'], 'description': 'wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing', 'armGroupLabels': ['Mepilex® Border Post-Op']}, {'name': 'standard wound dressing', 'type': 'DEVICE', 'otherNames': ['As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)'], 'description': 'standard wound dressing after hip-knee or spinal surgery', 'armGroupLabels': ['Standard wound dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Jan Bredow, physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jan Bredow', 'investigatorFullName': 'Jan Bredow', 'investigatorAffiliation': 'University of Cologne'}}}}