Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 2:01 AM
Study NCT ID:
NCT05824351
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.barto@duke.edu', 'phone': '919-684-1817', 'title': 'Amy Barto, MD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 days', 'description': 'Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data.', 'eventGroups': [{'id': 'EG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin redness/irritation', 'notes': 'Expected adverse event due to the adhesive bandage used, not the study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Draize Score for Erythema and Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.'}, {'id': 'OG001', 'title': 'Domestic Beeswax-pine Adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.'}, {'id': 'OG002', 'title': 'Control', 'description': "Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.\n\nHollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'title': 'Edema', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean of paired differences', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2571', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.70', 'groupDescription': 'Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'One-sided lower t-test', 'nonInferiorityComment': 'Equivalence is defined as an average difference of \\< or = 2'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean of paired differences', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0294', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.79', 'groupDescription': 'Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'One-sided upper t-test', 'nonInferiorityComment': 'Equivalence is defined as an average difference of \\< or = 2'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'description': 'The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 9 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.'}, {'id': 'OG001', 'title': 'Domestic Beeswax-pine Adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.'}, {'id': 'OG002', 'title': 'Control', 'description': "Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.\n\nHollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'description': 'The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the itching. The score ranges from 5 to 25, where a higher score indicates greater itching.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Less than 6hrs/day"', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': '"6-12 hrs/day"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Not Present"', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': '"Mild"', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '"Moderate"', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 14 days, day 14 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Getting worse"', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '"Unchanged"', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': '"Little bit better, but still present"', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '"Much better, but still present"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Completely resolved"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Not relevant/applicable"', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Never affects sleep"', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': '"Occasional delays in falling asleep"', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Never affects this activity"', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': '"Rarely affects this activity"', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '"Occasionally affects this activity"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Not relevant/applicable"', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Never affects this activity"', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': '"Rarely affects this activity"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Occasionally affects this activity"', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '"Not relevant/applicable"', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Never affects this activity"', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': '"Rarely affects this activity"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Occasionally affects this activity"', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '"Not relevant/applicable"', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'PRIMARY', 'title': 'Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'title': '"Broader Abdomen"', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '"Unchecked"', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '"Not relevant/applicable"', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data not collected on 2 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data.'}, {'type': 'SECONDARY', 'title': 'Overall Well-being as Measured by Daily Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily, days 1-7', 'description': 'Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Overall Well-being as Measured by Daily Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily, days 1-6', 'description': 'Number of participants who responded "yes" to the question, "Were you able to successfully remove and reattach all three samples + Tegaderm (the clear adhesive) today?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Overall Well-being as Measured by Daily Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily, days 1-7', 'description': 'Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control', 'description': "Each study subject will be tested with thin rings of three types of adhesive.\n\nTanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.\n\nDomestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.\n\nControl: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'spread': '6.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-10-28', 'size': 225235, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-30T17:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2023-03-20', 'resultsFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-30', 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Irritation as Measured by Draize Score for Erythema and Edema', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'description': 'The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe.'}, {'measure': 'Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported', 'description': 'The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the itching. The score ranges from 5 to 25, where a higher score indicates greater itching.'}, {'measure': 'Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"', 'timeFrame': 'Assessed daily up to 14 days, day 14 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection', 'timeFrame': 'Assessed daily up to 7 days, day 7 reported'}, {'measure': 'Overall Well-being as Measured by Daily Survey', 'timeFrame': 'Daily, days 1-7', 'description': 'Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?"'}, {'measure': 'Overall Well-being as Measured by Daily Survey', 'timeFrame': 'Daily, days 1-6', 'description': 'Number of participants who responded "yes" to the question, "Were you able to successfully remove and reattach all three samples + Tegaderm (the clear adhesive) today?"'}, {'measure': 'Overall Well-being as Measured by Daily Survey', 'timeFrame': 'Daily, days 1-7', 'description': 'Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Abdominal Site', 'Colostomy Site']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults with age +/\\>18 years\n* Recruited from Duke University\n* Local community members\n\nExclusion Criteria:\n\n* Any pre-existing skin conditions\n* Skin allergies to tegaderm or other adhesive products contained within the study and control rings'}, 'identificationModule': {'nctId': 'NCT05824351', 'briefTitle': 'LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Team LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa and Other Low Resource Settings.', 'orgStudyIdInfo': {'id': 'Pro00111440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tanzanian beeswax-pine adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.', 'interventionNames': ['Device: Tanzanian beeswax-pine resin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Domestic beeswax-pine adhesive', 'description': 'Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.', 'interventionNames': ['Device: Domestic beeswax-pine resin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.", 'interventionNames': ["Device: Hollister's AdaptTM Barrier Rings"]}], 'interventions': [{'name': 'Tanzanian beeswax-pine resin', 'type': 'DEVICE', 'description': 'Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.', 'armGroupLabels': ['Tanzanian beeswax-pine adhesive']}, {'name': 'Domestic beeswax-pine resin', 'type': 'DEVICE', 'description': 'Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.', 'armGroupLabels': ['Domestic beeswax-pine adhesive']}, {'name': "Hollister's AdaptTM Barrier Rings", 'type': 'DEVICE', 'description': "Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22210', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Denter', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Amy Barto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'VentureWell', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}