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This study will test a special powder for ulcers caused by a variety of conditions such as pressure that sometimes happen when a person is at the end of life. The powder will be applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who are being cared for by hospice or palliative care organizations will be invited to be in the study. The study will also find out if the powder is easy to use by caregivers as well as improving the comfort and quality of life of the person who has the ulcer.
Aim 1. In a comparative 2-group design, we will evaluate and compare the feasibility of the intervention through assessment in both settings (home-based and inpatient) on:
Aim 2. Estimate variability of outcome measurements and effect sizes and investigate the presence of a preliminary "signal" of clinical efficacy in two groups of hospice/home health/residential individuals receiving RGN107 in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound powder | Other | In both hospice settings, a registered nurse establishes the wound protocol per principles of wound care and agency guidelines. The cover dressing will be removed and the wound cleansed according to agency protocol (usual care) or as needed. The RGN107 powder, contained in a small squirt bottle, will be squeezed/sprinkled on the wound at each dressing change after cleansing or until a crust is formed. Once formed, the powder will be applied only minimally to reinforce crust integrity. The peri-wound skin will receive care and the cover dressing will be applied. Minimal manipulation of the crusted area will ensue once it has formed. Frequency of dressing changes depends on wound characteristics such as exudate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound powder application | Other | Powder application to wound per protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| adherence | adherence to RGN107 protocol by licensed care providers and/or family or other caregivers providing wound care; measures include implementation of procedures, frequency of dressing changes. | 4 weeks |
| reach | reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation. | 4 weeks |
| usability | usability issues such as powder ability to stick to wound and ease of use of applying powder. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms | physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales | 4 weeks |
| quality of life | quality of life of individuals receiving and caregivers using RGN107. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roper Hospice | Charleston | South Carolina | 29407 | United States | ||
| Hospice of Charleston |
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| Label | URL |
|---|---|
| Information about the study is available to the public at the above site. | View source |
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Data will be shared upon request and findings will be disseminated through publications and presentations.
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000632582 | RGN107 |
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| 4 weeks |
| North Charleston |
| South Carolina |
| 29406 |
| United States |
| Odyssey Hospice | North Charleston | South Carolina | 29406 | United States |