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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Teresa Kelechi, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02008487
First received: December 6, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention
Pressure Ulcer
End-of-life
Other: Wound powder application

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • adherence [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.

  • usability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    usability issues such as powder ability to stick to wound and ease of use of applying powder.


Secondary Outcome Measures:
  • symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales

  • quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    quality of life of individuals receiving and caregivers using RGN107.


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other Names:
  • RGN107
  • MittiHeal

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008487

Contacts
Contact: Moby Madisetti, MS 843-792-2059 madisett@musc.edu

Locations
United States, South Carolina
Roper Hospice Recruiting
Charleston, South Carolina, United States, 29407
Contact: Catherine S Meza, BSN    843-402-3260    catherine.meza@rsfh.com   
Odyssey Hospice Recruiting
North Charleston, South Carolina, United States, 29406
Contact: Anne Durant, MHA    843-554-4048    anne.durante@odsyhealth.com   
Hospice of Charleston Recruiting
North Charleston, South Carolina, United States, 29406
Contact: Kathy Miller, MSN    843-529-3100    mary.miller@gentiva.com   
Sponsors and Collaborators
Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Teresa Kelechi, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02008487     History of Changes
Other Study ID Numbers: 1R21NR014310
Study First Received: December 6, 2013
Last Updated: December 10, 2013
Health Authority: United States: National Institutes of Health; National Institute of Nursing Research

Keywords provided by Medical University of South Carolina:
end-of-life
palliative care
hospice
pressure ulcers

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014