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

Primary Purpose

Wounds and Injuries

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Altrazeal (R) Transforming Powder Dressing
Standard of Care burn dressing
Sponsored by
ULURU Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring burn

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
  • Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
  • Wounds must be partial thickness, involving up to 20% of the total body surface area.
  • Burn injury should be less than 36 hours old
  • Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Known allergy to TPD or its components

    • Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
  • Infected wounds
  • Presence of any full thickness (third degree) burns
  • Electrical burns
  • Heavily draining burns due to underlying chronic lymphedema or other conditions
  • Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.

  • History of poor wound healing and/or skin/immune system condition

    • Deemed by clinician not to be suitable
  • Unwilling or not able to provide consent or comply with protocol or required visits
  • Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
  • Active alcohol or substance abuse

Sites / Locations

  • MedStar Washington Hospital Center
  • University of Texas SW (Parkland)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transforming Powder Dressing

Standard of Care Dressing

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Pain from the Burn Wound
Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.

Secondary Outcome Measures

Wound healing
Wounds will measured at each study visit to determine surface area healing.
Safety of the Interventions (TPD and SOC)
Complications such as infection, and other adverse events that develop will be documented, evaluated for severity, and compared between intervention groups.
Subject satisfaction
Subjects will be asked to complete a subject satisfaction survey, which consists of 8 multiple choice questions regarding their wound dressing.

Full Information

First Posted
June 10, 2022
Last Updated
June 14, 2022
Sponsor
ULURU Inc.
Collaborators
Navy Advanced Medical Development (NAMD) Command
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1. Study Identification

Unique Protocol Identification Number
NCT05424354
Brief Title
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
Official Title
Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ULURU Inc.
Collaborators
Navy Advanced Medical Development (NAMD) Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.
Detailed Description
This post-marketing study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Prospective, Multi-Center, Open Label, Comparison, Human, Interventional
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transforming Powder Dressing
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care Dressing
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Altrazeal (R) Transforming Powder Dressing
Intervention Description
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.
Intervention Type
Other
Intervention Name(s)
Standard of Care burn dressing
Intervention Description
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.
Primary Outcome Measure Information:
Title
Pain from the Burn Wound
Description
Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.
Time Frame
28 days (or sooner if the wound heals prior to 28 days)
Secondary Outcome Measure Information:
Title
Wound healing
Description
Wounds will measured at each study visit to determine surface area healing.
Time Frame
28 days (or sooner if the wound heals prior to 28 days)
Title
Safety of the Interventions (TPD and SOC)
Description
Complications such as infection, and other adverse events that develop will be documented, evaluated for severity, and compared between intervention groups.
Time Frame
28 days (or sooner if the wound heals prior to 28 days)
Title
Subject satisfaction
Description
Subjects will be asked to complete a subject satisfaction survey, which consists of 8 multiple choice questions regarding their wound dressing.
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment. Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old Wounds must be partial thickness, involving up to 20% of the total body surface area. Burn injury should be less than 36 hours old Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations. Willing and able to provide written informed consent. Exclusion Criteria: Known allergy to TPD or its components Women who are pregnant, breast feeding, or plan to get pregnant during the study period. Infected wounds Presence of any full thickness (third degree) burns Electrical burns Heavily draining burns due to underlying chronic lymphedema or other conditions Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study. History of poor wound healing and/or skin/immune system condition Deemed by clinician not to be suitable Unwilling or not able to provide consent or comply with protocol or required visits Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol Active alcohol or substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Saxe, MD
Organizational Affiliation
ULURU Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Texas SW (Parkland)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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