Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Study Overview
=================
Brief Summary
-----------------
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a dressing, wound, hydrogel and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.

Detailed Description
-----------------
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin with redness to full thickness wounds with deep tissue loss and exposed bone. This study will focus on patients with stage 2, stage 3 and stage 4 pressure injury wounds. It will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® Transforming Powder Dressing (TPD). Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a dressing, wound, hydrogel and has an extended wear time of up to 30 days. Altrazeal® is a powder dressing that conforms to the wound, covering and protecting it, shielding the wound from bacteria. Altrazeal® is used in conjunction with a secondary dressing when needed. The primary aim of the study is to evaluate whether dressing changes can be reduced during treatment of pressure injuries. The study will also compare wound healing between the group receiving Altrazeal® and the group receiving standard of care dressings, as well as complications, pain, quality of life, and overall costs between the two groups. Subjects will be randomized into 2 groups, standard of care and Altrazeal®. Half of the subjects will receive current standard of care treatment, and the other half will receive treatment with Altrazeal®. This is an open-label study, meaning that both the subject and the treatment provider will know what study group the subject has been randomized to. The first visit will be the screening visit to ensure patients meet eligibility criteria. Patients can be either an outpatient or hospitalized. Written informed consent will be obtained during this visit. A wound evaluation will be performed, and laboratory work ordered, if not done recently. Once identified as meeting study criteria, the next visit is Baseline Visit, where randomization will occur and the first treatment will take place. Participants will be evaluated for 12 additional consecutive weeks, receiving wound evaluation, measurements, and getting treatment for the wound. A pain evaluation, quality of life survey related to having a wound, questionnaire regarding additional wound care performed between study visits. Participants will also answer questions regarding how much offloading devices or maneuvers were utilized, medications taken, and if any complications developed related to their wound care. If the wound is healed prior to 12 weeks, the study will end when the wound is healed. Otherwise, the study will go on for 12 consecutive weeks. At the end of the study, the participant will be asked to complete a Subject Satisfaction Survey, answering questions regarding how the wound dressing worked for them. The surveys should take 5-10 minutes to complete.

Official Title
-----------------
Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Conditions
-----------------
Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV

Intervention / Treatment
-----------------
* Device: Altrazeal® Transforming Powder Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 85 years of age; Stage 2, 3, or 4 Pressure Injuries; Wound exudate is mild to moderate; No clinically active wound infection (clinical diagnosis); Able and willing to provide written (not proxy) informed consent; Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment. Exclusion Criteria: Known allergy or hypersensitivity to TPD or its components; Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1; Heavily exudative wounds; Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema >0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge; Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months); Body Mass Index (BMI) >45 kg/m2; Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb); Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb); Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study; Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes; Wounds with necrosis unable to undergo prior definitive debridement; Fistulas; Active gangrene; Untreated HIV; Currently pregnant or lactating; Impending organ transplant; Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients; Unwilling or unable to comply with offloading recommendations; If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because: Unable to keep research appointments; Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound); Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes; Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules; Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study; Not suitable for study participation. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized, Prospective, Controlled, Open-label, Parallel Group, Multicenter
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Dressing for Pressure Injury<br>Standard wound dressings recommended by the National Pressure Injury Advisory Panel (NPIAP), according to the wound stage, will be utilized to treat pressure injuries. These include hydrocolloid, hydrogel, polymeric membranes, foam, collagen dressings, and negative pressure wound therapy. Dressings will be changed according to wound conditions, and type of dressing selected. | Device: Altrazeal® Transforming Powder Dressing<br>* Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm<br>* Other names: Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc);|
| Active Comparator: Altrazeal® Transforming Powder Dressing<br>Altrazeal® Transforming Powder Dressing will be applied during the Baseline visit. It should be left in place for up to 30 days, and topped off (additional powder applied if needed) at each subsequent visit. Secondary dressing, including a contact layer over the Altrazeal® and a secondary dressing (like gauze or foam) may be applied over the contact layer. | Device: Altrazeal® Transforming Powder Dressing<br>* Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm<br>* Other names: Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of wound dressing changes | The number of primary dressing changes for each treatment group will be compared. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing will be measured by using a ruler each week to report length and width of the wound. Percentage of wound area reduction will be calculated for each treatment group and compared. | 12 weeks | 
| Complications (problems) from treating the pressure wound | Subjects will be asked to report, will be questioned and observed (by the researchers) each study visit for any complications, problems or adverse events related to the study wound that they experience, such as maceration around the wound from the drainage, moisture, or dressing. Complications and adverse events will be compared during the course of the study | 12 weeks | 
| Pain in the wound and from dressing changes. | Subjects with sensation in the area of the wound will be asked to complete a validated visual analogue scale. This is a simple validated test asking the subject to rate their pain on a 0-10 point level, where 10 is the worst and 0 is no pain. Mean and median pain scores will be compared for each treatment group during the course of the study | 12 weeks | 
| Wound Quality of Life | Mean and median changes in validated Wound Quality of Life scores will be measured between groups during the course of the study | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound care, Quality of life, Pain