Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

Phase 4

Waitlist Available

Led By Jonathan Saxe, 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 28 days (or sooner if the wound heals prior to 28 days)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a special powder that turns into a protective layer for treating recent partial thickness burns in adults. The goal is to see if it helps burns heal faster and reduces pain compared to other treatments.

Eligible Conditions

Wound
Wounds and Injuries

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days (or sooner if the wound heals prior to 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days (or sooner if the wound heals prior to 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (or sooner if the wound heals prior to 28 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain from the Burn Wound

Secondary study objectives

Safety of the Interventions (TPD and SOC)

Subject satisfaction

Wound healing

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transforming Powder DressingExperimental Treatment1 Intervention

Half of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

Group II: Standard of Care DressingActive Control1 Intervention

Half of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

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