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Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraHoney HD | Active Comparator | Honey product |
|
| SkinTegrity | Active Comparator | Skin moisturizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraHoney HD | Device | Honey |
| |
| SkinTegrity |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Wounds Healed | Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Chaiken, RN | Swedish Covenant Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Covenant Hospital | Chicago | Illinois | 606025 | United States | ||
| Harmony Residential Facility |
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| ID | Title | Description |
|---|---|---|
| FG000 | TheraHoney HD | Honey product TheraHoney HD: Honey |
| FG001 | SkinTegrity | Skin moisturizer SkinTegrity: Hydrogel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TheraHoney HD | Honey product TheraHoney HD: Honey |
| BG001 | SkinTegrity | Skin moisturizer SkinTegrity: Hydrogel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Wounds Healed | Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer | Posted | Mean | Standard Deviation | percentage of wounds | 3 weeks |
|
|
wound treatment period of 34 days
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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 | TheraHoney HD | Honey product TheraHoney HD: Honey | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection/sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periwound Maceration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Chaiken | Swedish Covenant Hospital | 847-372-3500 | nchaiken@comcast.net |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
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| Device |
Hydrogel |
|
|
| Chicago |
| Illinois |
| 60625 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events | Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| 11 |
| 1 |
| 11 |
| 1 |
| 11 |
| EG001 | SkinTegrity | Skin moisturizer SkinTegrity: Hydrogel | 0 | 10 | 2 | 10 | 1 | 10 |
| Ischemic Bowel Surgery | Gastrointestinal disorders | Systematic Assessment |
|
| AFIB | Cardiac disorders | Systematic Assessment |
|
| Increased Wound Size | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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