Wound Powder for Pressure Ulcers at End-of-life
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - 105 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | March 2016 |
Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life
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.
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:
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.
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.
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)
We found this trial at
3
sites
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