Clinical Trials Logo
  1. Home
  2. Pressure Ulcer
  3. NCT02008487

Wound Powder for Pressure Ulcers at End-of-life — RGN107  

Pressure Ulcer Clinical Trial

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

Clinical 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). 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.

Clinical Trial 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02008487
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date April 2013
Completion date March 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT03351049 - An RCT on Support Surfaces for Pressure Ulcer Prevention N/A
Completed NCT05112068 - Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Completed NCT05575869 - Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Completed NCT04540822 - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care N/A
Terminated NCT05234632 - Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01438541 - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration Phase 4
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT04251897 - Novel Support Surface to Alleviate Pressure Ulcer N/A
Completed NCT03391310 - Use of Honey for Pressure Ulcers in Critically Ill Children N/A
Recruiting NCT04559165 - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT06421454 - Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers N/A
Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A