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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05462860
• Other study ID #: Suprathel
• Secondary ID: CDMRP-MB200024
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: September 29, 2024

Study information

• Verified date: October 2022
• Source: The Metis Foundation
• Contact: Victoria Diaz, RN
• Phone: 2105691140
• Email: Diaz[@]metisfoundationusa.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Wound of Skin
• Wounds and Injuries

Intervention

Other:
• Suprathel®
Application of standard of care dressing.®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Metis Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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