Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Wound of Skin
• Intervention / Treatment: Other: Suprathel®

Detailed Description

We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Diaz, RN; Phone Number: 2105691140; Email: diaz@metisfoundationusa.org
• Study Contact Backup: Name: Kristin Anselmo; Email: Anselmo@metisfoundationusa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female ≥18 years and ≤75 years
• Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
• TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
• TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
• Subject is able and willing to sign Informed Consent or via legally authorized representative

Exclusion Criteria:

• Study Wound due to electrical, radioactive, or frostbite-related injury
• Infection of wounds in the study area at admission per Investigator or treating physician discretion
• Pregnancy/lactation
• Subjects who are unable to follow the protocol or who are likely to be non-compliant
• Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
• Prisoners
• Life expectancy less than 6 months
• Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.	Other: Suprathel®; Application of standard of care dressing.®; Other Names: standard of care
Experimental: Suprathel® dressing; The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use	Other: Suprathel®; Application of standard of care dressing.®; Other Names: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for autograft application	The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound infection rate, wound closure of the region	Incidence of infections and inflammatory response and scar development	2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart)
Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).	Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.	Mid (3-9 months) and long term (52 weeks)
Patient-reported perception of pain based on the Visual Analog Scale	Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.	After initial application (Day 0) and weekly

Collaborators and Investigators

• Sponsor: The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): September 29, 2024
• Study Completion (Anticipated): September 29, 2024

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: Suprathel; CDMRP-MB200024 (Other Grant/Funding Number: Congressionally Directed Medical Research Program Office)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No