Wound of SkinNCT05462860
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
A study testing Suprathel® in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wound of Skin, Burns
- What is being tested?
- Suprathel®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 9 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Wound of Skin, Burns
- Being tested
- Suprathel®
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathel®Other
Also called standard of care
Application of standard of care dressing.®
| Study group | Role | What they receive |
|---|---|---|
| Suprathel® dressing | Experimental | 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 Receives: Other: Suprathel® |
| Standard of Care | Active comparator | 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. Receives: Other: Suprathel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (3)
Wound infection rate, wound closure of the region
Incidence of infections and inflammatory response and scar development
Measured: 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.
Measured: 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.
Measured: After initial application (Day 0) and weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start18 Sep 2024
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Proof of concept
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462860
- Sponsor's protocol ID
- Suprathel
- Other IDs
- CDMRP-MB200024
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
- ClinicalTrials.gov ID
- NCT05462860
- Acronym / sponsor ID
- Suprathel
- Conditions
- Wound of Skin, Burns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Proof of concept
| Arm | Type | Receives |
|---|---|---|
| Suprathel® dressing | Experimental | Other: Suprathel®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 |
| Standard of Care | Active comparator | Other: Suprathel®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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprathel®Also: standard of careApplication of standard of care dressing.® | Other | Standard of Care, Suprathel® dressing |
Primary outcome
Need for autograft application
Time frame: 21 days
The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.
3 secondary outcomes
Wound infection rate, wound closure of the region
Time frame: 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).
Time frame: Mid (3-9 months) and long term (52 weeks)
Patient-reported perception of pain based on the Visual Analog Scale
Time frame: After initial application (Day 0) and weekly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney Chan, MD principal investigator
Metis Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprathel® in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for autograft application (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.