RGN107: Wound Powder for Pressure Ulcers at End-of-life

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT02008487

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

16.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer Wounds	Other: Wound powder application	N/A

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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Wound powder 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 Powder application to wound per protocol. Other Names: RGN107 MittiHeal

Arm

Intervention/Treatment

Other: Wound powder

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

Powder application to wound per protocol.

Other Names:

RGN107

MittiHeal

Outcome Measures

Primary Outcome Measures

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.
reach [4 weeks]
reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.
usability [4 weeks]
usability issues such as powder ability to stick to wound and ease of use of applying powder.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roper Hospice	Charleston	South Carolina	United States	29407
2	Hospice of Charleston	North Charleston	South Carolina	United States	29406
3	Odyssey Hospice	North Charleston	South Carolina	United States	29406