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| Name | Class |
|---|---|
| Oculus Innovative Sciences, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcyn | Experimental | 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. |
|
| Sterile saline | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcyn | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline | 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. | pressure ulcer size (length x width x depth, cm^3) at baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline | 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. | 4 weeks after baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline | 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. | 8 weeks after baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline | 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. | 12 weeks after baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline | 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 | Description | Time Frame |
|---|---|---|
| Pressure Ulcer Scale for Healing (PUSH) Score | 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). | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuying Chen, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microcyn | 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 |
| FG001 | Sterile Saline | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Microcyn arm: there were 8 people were lost to follow up. Sterile saline arm: there were 14 people lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Microcyn | 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 |
| BG001 | Sterile Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline | 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. | Posted | Median | Full Range | cm^3 | pressure ulcer size (length x width x depth, cm^3) at baseline |
|
From baseline through 53 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microcyn | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuying Chen, MD, PhD | University of Alabama at Birmingham | 205-934-3329 | yuyingchen@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Aug 20, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013118 | Spinal Cord Diseases |
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| ID | Term |
|---|---|
| D011310 | Preservatives, Pharmaceutical |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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|
| Sterile saline | Other | 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 |
|
| 16 weeks after baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline | 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. | 20 weeks after baseline |
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline | 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. | 24 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline |
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). |
| 4 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline | 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). | 8 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline | 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). | 12 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline | 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). | 16 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline | 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). | 20 weeks after baseline |
| Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline | 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). | 24 weeks after baseline |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline | 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. | Microcyn arm: there were 8 participants lost to follow up during this evaluation period. Sterile saline arm: there were 10 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 4 weeks after baseline |
|
|
|
| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline | 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. | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 17 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 8 weeks after baseline |
|
|
|
| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline | 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. | Microcyn arm: there were 9 participants lost to follow up during this evaluation period. Sterile saline arm: there were 18 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 12 weeks after baseline |
|
|
|
| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline | 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. | Microcyn arm: there were 13 participants lost to follow up during this evaluation period. Sterile saline arm: there were 19 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 16 weeks after baseline |
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| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline | 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. | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 25 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 20 weeks after baseline |
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| Primary | Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline | 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. | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 19 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | cm^3 | 24 weeks after baseline |
|
|
|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score | 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). | Posted | Median | Full Range | score on a scale | at baseline |
|
|
|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline | 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). | Microcyn arm: there were 8 participants lost to follow up during this evaluation period. Sterile saline arm: there were 12 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 4 weeks after baseline |
|
|
|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline | 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). | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 17 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 8 weeks after baseline |
|
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| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline | 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). | Microcyn arm: there were 9 participants lost to follow up during this evaluation period. Sterile saline arm: there were 19 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 12 weeks after baseline |
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|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline | 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). | Microcyn arm: there were 13 participants lost to follow up during this evaluation period. Sterile saline arm: there were 19 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 16 weeks after baseline |
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| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline | 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). | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 25 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 20 weeks after baseline |
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|
|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline | 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). | Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 19 participants lost to follow up during this evaluation period. | Posted | Median | Full Range | score on a scale | 24 weeks after baseline |
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|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Sterile Saline | 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 | 0 | 33 | 0 | 33 | 0 | 33 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |