Wound Powder for Pressure Ulcers at End-of-life

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation. Usability issues such as powder ability to stick to wound and ease of use of applying powder. 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: Physical wound symptoms outcomes, specifically pain, odor and exudate. Quality of life of individuals receiving and caregivers using RGN107.

Official Title
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Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life

Conditions
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Pressure Ulcer, Wounds

Intervention / Treatment
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* Other: Wound powder application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 years or older Patient prognosis > 1 month and < 6 months Pressure wounds Pain or odor or exudate score > 2 on VAS Wound caregiver able to perform required protocol activities Exclusion Criteria: Known allergies to Turmeric, Mint, Sandalwood Using negative pressure wound therapy Currently using topical creams or ointments applied to wound bed (powder will not adhere to these products) Wound with eschar covering (powder will not stick)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wound powder<br>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. | Other: Wound powder application<br>* Powder application to wound per protocol.<br>* Other names: MittiHeal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound, palliative care, hospice, pressure ulcers