Wound Powder for Pressure Ulcers at End-of-life

Pressure Ulcer Clinical Trial

— RGN107  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008487
• Other study ID #: 1R21NR014310
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: April 4, 2016
• Start date: April 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 105 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pressure Ulcer
• Wounds

Intervention

Other:
• Wound powder application
Powder application to wound per protocol.

Locations

Country	Name	City	State
United States	Roper Hospice	Charleston	South Carolina
United States	Hospice of Charleston	North Charleston	South Carolina
United States	Odyssey Hospice	North Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	reach	reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.	4 weeks	No
Primary	usability	usability issues such as powder ability to stick to wound and ease of use of applying powder.	4 weeks	No
Secondary	symptoms	physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales	4 weeks	No
Secondary	quality of life	quality of life of individuals receiving and caregivers using RGN107.	4 weeks	No

External Links

•   Information about the study is available to the public at the above site.