Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-03 @ 4:10 PM
Study NCT ID:
NCT01442103
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2011-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joan.wilson@molnlycke.com', 'phone': '+1 706-650-1012', 'title': 'Joan wilson', 'organization': 'Molnlycke Health Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small study population, 2 patients lost to follow-up.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Device Common Dressing', 'description': 'Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Common Dressing', 'description': 'Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (\\>80%) water content and water soluble polymer chains.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.'}, {'type': 'SECONDARY', 'title': 'Infection Assessment', 'timeFrame': '4 weekks', 'description': 'Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Upon Application of Investigational Product.', 'timeFrame': '4 weeks', 'description': 'VAS pain scale will be used to measuring pain at each dressing change.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Silver Gel, Chronic Wounds', 'description': 'The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The recruitment period was from 15 September 2011 - 01 May 2012. The study was conducted at the Advanced Burn and Wound Clinic at the Joseph M. Still Burn Center in Augusta, Georgia.', 'preAssignmentDetails': 'PreAssignment details:\n\nThere was not wash-out or run-in phase included in the study. Subjects were expected to have at least 2 signs of local irritation or inflammation but no active or systemic infection at the time of consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Silver Gel, Chronic Wounds', 'description': 'Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '18.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2011-09-13', 'resultsFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-16', 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.', 'timeFrame': '4 weeks', 'description': 'Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.'}], 'secondaryOutcomes': [{'measure': 'Infection Assessment', 'timeFrame': '4 weekks', 'description': 'Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.'}, {'measure': 'Pain Upon Application of Investigational Product.', 'timeFrame': '4 weeks', 'description': 'VAS pain scale will be used to measuring pain at each dressing change.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Wounds']}, 'descriptionModule': {'briefSummary': 'This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.', 'detailedDescription': 'Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent\n2. Both genders with an age \\>18 years\n3. Subjects with chronic wounds \\< 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:\n\n * Erythema\n * Edema\n * Warmth\n * Increased drainage\n * Foul odor\n4. Subject's wounds may also present with:\n\n * presence of eschar or slough that needs to be treated prior to normal standard of care OR\n * A need for topical care after debridement\n5. Study site to include only ONE wound to be treated\n\nExclusion Criteria:\n\n1. Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.\n2. Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days\n3. Wound \\> 1 year old\n4. Wound \\> 10 cm x 10 cm (l x w)\n5. Wound \\> 6 cm deep\n6. Use of chemical/enzymatic and biological debridement within 7 days of investigation start\n7. Necrotizing wounds\n8. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.\n9. Subjects with poorly controlled diabetes mellitus (as judged by the investigator).\n10. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.\n11. Known allergy/hypersensitivity to any of the components of the investigation products.\n12. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.\n13. Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation"}, 'identificationModule': {'nctId': 'NCT01442103', 'briefTitle': 'Clinical Utility of a New Silver Gel for Use on Chronic Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': 'Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds', 'orgStudyIdInfo': {'id': 'Ngel Ag 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device, dressing', 'description': 'Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.', 'interventionNames': ['Device: Normlgel Ag']}], 'interventions': [{'name': 'Normlgel Ag', 'type': 'DEVICE', 'description': 'Normlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log.', 'armGroupLabels': ['Device, dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Joseph M. Still Research Foundation, Inc.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Zaheed Hassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Josepth M. Still Research Foundation, Augusta, Georgia, US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molnlycke Health Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}