Wound Powder for Pressure Ulcers at End-of-life (RGN107)

April 4, 2016 updated by: Teresa Kelechi, Medical University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Roper Hospice
      • North Charleston, South Carolina, United States, 29406
        • Hospice of Charleston
      • North Charleston, South Carolina, United States, 29406
        • Odyssey Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 105 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms
Time Frame: 4 weeks
physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales
4 weeks
quality of life
Time Frame: 4 weeks
quality of life of individuals receiving and caregivers using RGN107.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21NR014310 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon request and findings will be disseminated through publications and presentations.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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