Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 9:30 PM
Study NCT ID:
NCT05499104
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2021-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-31', 'mcpReleaseN': 1, 'releaseDate': '2023-03-07'}, {'resetDate': '2023-10-20', 'mcpReleaseN': 2, 'releaseDate': '2023-09-26'}], 'estimatedResultsFirstSubmitDate': '2023-03-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and Healing', 'timeFrame': '14 days', 'description': 'To compare and healing (defined as \\>95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing.'}], 'secondaryOutcomes': [{'measure': 'Absorbent ability', 'timeFrame': '14 days', 'description': 'Ability of dressing to absorb exudate measured by staff satisfaction survey'}, {'measure': 'Conformability', 'timeFrame': '14 days', 'description': 'Ability of dressing to maintain shape measured by staff satisfaction survey'}, {'measure': 'Adherence', 'timeFrame': '14 days', 'description': 'Ability of dressing to remain fixed in place measured by staff satisfaction survey'}, {'measure': 'Management of bloody exudate', 'timeFrame': '14 days', 'description': 'Ability of dressing to absorb bloody exudate measured by staff satisfaction survey'}, {'measure': 'Ease of removal', 'timeFrame': '14 days', 'description': 'Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey'}, {'measure': 'Cost', 'timeFrame': '14 days', 'description': 'Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Donor Sites', 'Wound Heal', 'Wound Drainage', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is ≥18 years of age.\n* Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.\n* Subject is able to provide informed consent.\n* Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.\n\nExclusion Criteria:\n\n* Has a Baux Score of ≥130.\n* Subject is intubated, unable to state pain levels.\n* Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,\n* Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.\n* Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).\n* Is pregnant, plans to become pregnant, or is actively breastfeeding.\n* Active illicit drug use.\n* Is moribund, or in the opinion of the investigator is not expected to survive.'}, 'identificationModule': {'nctId': 'NCT05499104', 'briefTitle': 'A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Joseph M. Still Research Foundation, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Controlled Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.', 'orgStudyIdInfo': {'id': 'JMSRF-NCMIS-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mepilex Ag', 'description': 'patient will receive Mepilex Ag for their site, standard of care to be followed.', 'interventionNames': ['Device: Mepilex Ag']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xeroform', 'description': 'patient will receive Xeroform for their site, standard of care to be followed.', 'interventionNames': ['Device: Xeroform']}, {'type': 'EXPERIMENTAL', 'label': 'NovaDress', 'description': 'patient will receive NovaDress for their site, standard of care to be followed.', 'interventionNames': ['Device: NovaDress']}], 'interventions': [{'name': 'NovaDress', 'type': 'DEVICE', 'description': 'NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated.', 'armGroupLabels': ['NovaDress']}, {'name': 'Mepilex Ag', 'type': 'DEVICE', 'description': 'Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.', 'armGroupLabels': ['Mepilex Ag']}, {'name': 'Xeroform', 'type': 'DEVICE', 'description': 'Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.', 'armGroupLabels': ['Xeroform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Joseph M. Still Research Foundation', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph M. Still Research Foundation, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovatech Engineering, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}