Suprathel

About this trial

Last updated 3 years ago

Study ID

Suprathel

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 75 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended a year ago

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.

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

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