Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-18 @ 11:03 PM
Study NCT ID:
NCT02001558
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pressure Ulcer Healing With Microcyn
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011310', 'term': 'Preservatives, Pharmaceutical'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yuyingchen@uabmc.edu', 'phone': '205-934-3329', 'title': 'Yuying Chen, MD, PhD', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline through 53 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '10.13', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '196.00'}, {'value': '21.00', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '269.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pressure ulcer size (length x width x depth, cm^3) at baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '202.50'}, {'value': '15.75', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '160.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 8 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 10 participants lost to follow up during this evaluation period.'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '216.13'}, {'value': '20.06', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '165.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 17 participants lost to follow up during this evaluation period.'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '7.50', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '229.50'}, {'value': '19.25', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '224.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 9 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 18 participants lost to follow up during this evaluation period.'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '267.75'}, {'value': '11.63', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '123.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 13 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 19 participants lost to follow up during this evaluation period.'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '285.00'}, {'value': '9.75', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '72.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '20 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 25 participants lost to follow up during this evaluation period.'}, {'type': 'PRIMARY', 'title': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '200.00'}, {'value': '8.68', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '198.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 19 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '15.00'}, {'value': '12.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '15.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '17.00'}, {'value': '11.00', 'groupId': 'OG001', 'lowerLimit': '2.60', 'upperLimit': '16.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 8 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 12 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '11.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '15.00'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '15.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 17 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '15.00'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '15.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 9 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 19 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '14.00'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '13.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 13 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 19 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '11.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '14.00'}, {'value': '10.50', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '14.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '20 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 25 participants lost to follow up during this evaluation period.'}, {'type': 'SECONDARY', 'title': 'Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'OG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '10.50', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '15.00'}, {'value': '11.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '15.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microcyn arm: there were 12 participants lost to follow up during this evaluation period.\n\nSterile saline arm: there were 19 participants lost to follow up during this evaluation period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'FG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Microcyn', 'description': 'Microcyn: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24'}, {'id': 'BG001', 'title': 'Sterile Saline', 'description': 'Sterile saline: Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.75', 'spread': '13.37', 'groupId': 'BG000'}, {'value': '39.24', 'spread': '11.17', 'groupId': 'BG001'}, {'value': '39.98', 'spread': '12.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Microcyn arm: there were 8 people were lost to follow up. Sterile saline arm: there were 14 people lost to follow up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-31', 'size': 5585171, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-20T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2013-11-18', 'resultsFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline', 'timeFrame': 'pressure ulcer size (length x width x depth, cm^3) at baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline', 'timeFrame': '4 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline', 'timeFrame': '8 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline', 'timeFrame': '12 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline', 'timeFrame': '16 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline', 'timeFrame': '20 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}, {'measure': 'Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline', 'timeFrame': '24 weeks after baseline', 'description': 'Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.'}], 'secondaryOutcomes': [{'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score', 'timeFrame': 'at baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline', 'timeFrame': '4 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline', 'timeFrame': '8 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline', 'timeFrame': '12 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline', 'timeFrame': '16 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline', 'timeFrame': '20 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}, {'measure': 'Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline', 'timeFrame': '24 weeks after baseline', 'description': 'PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal cord injuries', 'Pressure ulcer'], 'conditions': ['Pressure Ulcer', 'Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 17 years\n* Persons with spinal cord injury\n* Having Stage III/IV pressure ulcer(s)\n* Able to fulfill all obligations of the study\n\nExclusion Criteria:\n\n* Pressure ulcers scheduled for surgical closure within 14 days\n* Use of any immunosuppressant medications within 30 days of screening\n* Having conditions that put the subject at significant risk\n* Medically unstable or has a life expectancy of less than 12 months\n* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02001558', 'briefTitle': 'Pressure Ulcer Healing With Microcyn', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Six Month Randomized Open-Label Trial of Pressure Ulcer Healing With Microcyn® Skin and Wound Care With Preservatives Versus Sterile Saline in Adult Spinal Cord Injury Subjects', 'orgStudyIdInfo': {'id': 'MIC-UABWC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microcyn', 'description': 'Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily.', 'interventionNames': ['Drug: Microcyn']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sterile saline', 'description': 'Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily.', 'interventionNames': ['Other: Sterile saline']}], 'interventions': [{'name': 'Microcyn', 'type': 'DRUG', 'otherNames': ['Microcyn® Skin and Wound Care with preservatives'], 'description': 'Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24', 'armGroupLabels': ['Microcyn']}, {'name': 'Sterile saline', 'type': 'OTHER', 'description': 'Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24', 'armGroupLabels': ['Sterile saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Yuying Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oculus Innovative Sciences, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yu-ying Chen', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}