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Completed

NCT Number: NCT02008487

Wound Powder for Pressure Ulcers 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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wounds Wounds and Injuries

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roper Hospice, Charleston, South Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wound powder application

Other

Powder application to wound per protocol.

Other names: RGN107, MittiHeal

Primary outcomes

  1. 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.

  2. 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.

  3. usability

    Time frame: 4 weeks

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

Secondary outcomes

  1. symptoms

    Time frame: 4 weeks

    physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales

  2. quality of life

    Time frame: 4 weeks

    quality of life of individuals receiving and caregivers using RGN107.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Acronym: RGN107

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 11, 2013
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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