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

Wounds and Injuries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05424354
• Other study ID #: U-C-TPD-2021-02
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 26, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: ULURU Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• Altrazeal (R) Transforming Powder Dressing
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.

Other:
• Standard of Care burn dressing
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.

Locations

Country	Name	City	State
United States	University of Texas SW (Parkland)	Dallas	Texas
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
ULURU Inc.	Navy Advanced Medical Development (NAMD) Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days (or sooner if the wound heals prior to 28 days)
Secondary	Wound healing	Wounds will measured at each study visit to determine surface area healing.	28 days (or sooner if the wound heals prior to 28 days)
Secondary	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.	28 days (or sooner if the wound heals prior to 28 days)
Secondary	Subject satisfaction	Subjects will be asked to complete a subject satisfaction survey, which consists of 8 multiple choice questions regarding their wound dressing.	End of Study