Wound Powder for Pressure Ulcers at End-of-life

NCT02008487 | Completed DMC

• 1 other identifier: 1R21NR014310
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Pressure Ulcer; Wounds

Keywords

wound; palliative care; hospice; pressure ulcers

Outcome Measures

Primary Outcomes (3)

• 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

• reach

  reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.

  4 weeks

• usability

  usability issues such as powder ability to stick to wound and ease of use of applying powder.

  4 weeks

Secondary Outcomes (2)

• symptoms

  4 weeks

• quality of life

  4 weeks

Study Arms (1)

Wound powder

OTHER

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

Interventions

Wound powder application OTHER

Powder application to wound per protocol.

Also known as: RGN107, MittiHeal

Wound powder

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (3)

Roper Hospice

Charleston, South Carolina, 29407, United States

Location

Hospice of Charleston

North Charleston, South Carolina, 29406, United States

Location

Odyssey Hospice

North Charleston, South Carolina, 29406, United States

Location

Related Links

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

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Interventions

RGN107

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)