Transforming Powder Dressing for Pressure Sores

N/A

Waitlist Available

Led By Saxe Johathan, MD

Research Sponsored by ULURU Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the effectiveness of Altrazeal® for patients with severe pressure ulcers. Altrazeal® is a powder that forms a protective cover over wounds, helping them heal. The study aims to see if Altrazeal® can reduce dressing changes and improve healing. Altrazeal® offers a promising new form of wound treatment.

Eligible Conditions

Bed sore
Bedsores

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of wound dressing changes

Secondary study objectives

Complications (problems) from treating the pressure wound

Pain in the wound and from dressing changes.

Wound Quality of Life

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Altrazeal® Transforming Powder DressingActive Control1 Intervention

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.

Group II: Standard of Care Dressing for Pressure InjuryActive Control1 Intervention

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.

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