Pressure Ulcer, Wounds
Conditions
Keywords
wound, palliative care, hospice, pressure ulcers
Brief summary
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
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: 1. 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. 2. Reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation. 3. 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: 1. Physical wound symptoms outcomes, specifically pain, odor and exudate. 2. Quality of life of individuals receiving and caregivers using RGN107.
Interventions
OTHERWound powder application
Powder application to wound per protocol.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reach | 4 weeks | reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation. |
| adherence | 4 weeks | 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. |
| usability | 4 weeks | usability issues such as powder ability to stick to wound and ease of use of applying powder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptoms | 4 weeks | physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales |
| quality of life | 4 weeks | quality of life of individuals receiving and caregivers using RGN107. |
Countries
United States
Outcome results
None listed