Clinical trial NCT02008487: Wound Powder for Pressure Ulcers at End-of-life
Official title: Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Wounds
Keywords: wound
palliative care
hospice
pressure ulcers
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: adherence
timeFrame: 4 weeks
measure: reach
timeFrame: 4 weeks
measure: usability
timeFrame: 4 weeks
Secondary outcomes:
measure: symptoms
timeFrame: 4 weeks
measure: quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Roper Hospice
state: South Carolina
city: North Charleston
country: United States
facility: Hospice of Charleston
state: South Carolina
city: North Charleston
country: United States
facility: Odyssey Hospice
state: South Carolina
Study officials:
References: