Pressure UlcerRGN107NCT02008487
Wound Powder for Pressure Ulcers at End-of-life
A study testing Wound powder application in people with Pressure Ulcer and Wounds, run by Medical University of South Carolina at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Pressure Ulcer, Wounds
- What is being tested?
- Wound powder application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roper Hospice
Charleston, South Carolina, 29407
Hospice of Charleston
North Charleston, South Carolina, 29406
Odyssey Hospice
North Charleston, South Carolina, 29406
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Pressure Ulcer, Wounds
- Being tested
- Wound powder application
- Keywords
- wound, palliative care, hospice, pressure ulcers
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound powder applicationOther
Also called RGN107, MittiHeal
Powder application to wound per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wound powder application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
reach
reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.
Measured: 4 weeks
usability
usability issues such as powder ability to stick to wound and ease of use of applying powder.
Measured: 4 weeks
Secondary outcomes (2)
symptoms
physical wound symptoms outcomes, specifically pain, odor and exudate will be measured with visual analog scales
Measured: 4 weeks
quality of life
quality of life of individuals receiving and caregivers using RGN107.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Kelechi, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008487
- Sponsor's protocol ID
- 1R21NR014310
- Acronym
- RGN107
- Status last verified
- Apr 2016
- First submitted
- 6 Dec 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared upon request and findings will be disseminated through publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life
- ClinicalTrials.gov ID
- NCT02008487
- Acronym / sponsor ID
- RGN107 / 1R21NR014310
- Conditions
- Pressure Ulcer, Wounds
- Keywords
- wound, palliative care, hospice, pressure ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wound powder | Other | Other: Wound powder applicationIn 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. |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound powder applicationAlso: RGN107, MittiHealPowder application to wound per protocol. | Other | Wound powder |
Primary outcome
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.
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.
usability
Time frame: 4 weeks
usability issues such as powder ability to stick to wound and ease of use of applying powder.
2 secondary outcomes
symptoms
Time frame: 4 weeks
quality of life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Information about the study is available to the public at the above site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared upon request and findings will be disseminated through publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound powder application in people with Pressure Ulcer and Wounds, run by Medical University of South Carolina at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.