Partial-thickness Burn WoundsPhase 4LOGINCT07326657
Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns
A Phase 4 study testing Intact fish skin graft and autograft in people with Partial-thickness Burn Wounds, run by Kerecis Ltd. at 1 site in United States.
Trial summary
The goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial-thickness Burn Wounds
- What is being tested?
- Intact fish skin graft and autograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jan 2029
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at time of consent
- Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated.
- Be able to provide written informed consent or have a legally authorized representative
- Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting.
- Investigator expects that the donor site will heal without grafting
- Have a complex skin defect of 3 to 49% Total Body Surface Area, which can consist of more than one contiguous area
Show all 13Show fewer
- At the time of debridement:
- Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
- Study treatment areas can be up to 2000 cm2
- Must have at least 100 cm2 TBSA for which autografting is indicated and on which IFSG can be applied, which may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
- Application of IFSG or SOC must be initiated within 14 days of injury (Application of IFSG or SOC must be initiated within 14 days of injury)
- Have first excision and grafting of study treatment sites
- Have thermal burn(s) on the torso or extremities
Who cannot join
- Known allergy or hypersensitivity to fish (shellfish allergy is OK)
- Female who is actively pregnant or currently breast-feeding
- Vulnerable populations
- Currently receiving systemic immunosuppressive therapy
- Current or known history of malignancy or receipt of chemotherapy
- History of Diabetes with documented uncontrolled diabetes (as defined by an A1C >9) within the last 6 months
Show all 14Show fewer
- Have an expected survival of less than 3 months
- Are currently participating/have participated in the treatment group of an interventional study within 90 calendar days prior to consent
- Have other wounds present for > 30 days
- At the time of debridement:
- Treatment area is assessed as full-thickness after debridement
- Treatment areas on the face, neck, head, hands, feet, buttocks, perineum, and areas over joints (Treatment areas may only be on the torso or extremities)
- Have a clinical or laboratory determination of infection at the anticipated treatment sites.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Open-label, Controlled, Randomized, Multicenter Study Evaluating Intact Fish Skin Graft in Promoting AutoLOgous Skin Tissue ReGeneratIon of Deep Partial-Thickness Burns: The LOGI Study
The goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft treatment is clinically indicated. This clinical trial seeks to collect the following:
- Difference in the percentage area of the IFSG treatment site and control autograft treatment site that required autografting within 1 month of treatment
- Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment
- Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment
- Difference in the pain intensity between the IFSG treatment site and autograft treatment site
Each participant will receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn. Participants will be assessed for the need for further autograft treatment. Participants will also be assessed for wound closure, pain, and cosmesis.
- Conditions
- Partial-thickness Burn Wounds
- Being tested
- Intact fish skin graft, autograft
- Keywords
- burn, deep partial-thickness, Kerecis, fish skin graft, autograft, split thickness skin graft, fish skin
- Medical subject headings
- Burns, Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact fish skin graftDevice
Treatment with IFSG
autograftProcedure or surgery
Treatment with autograft
| Study group | Role | What they receive |
|---|---|---|
| IFSG-Treated Area of Burn | Experimental | The area of the deep partial-thickness burn that is treated with IFSG Receives: Device: Intact fish skin graft |
| SOC Autograft-Treated Area of Burn | Active comparator | The area of the deep partial-thickness burn that is treated with autograft as standard-of-care Receives: Procedure: autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.
Measured: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later
Secondary outcomes (3)
Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement
Measured: From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later
Difference in cosmesis between the IFSG treatment site and autograft treatment site at Month 12 based on observer POSAS total score
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) that describes scar quality on a scale from 1-10 with 1 being a scar very similar to normal skin and 10 being a severe scar very unlike normal skin.
Measured: From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later
Difference in the pain intensity between the IFSG treatment site and autograft treatment site one week after treatment based on the Wong-Baker FACES pain rating scale (FPRS)
The Wong-Baker FACES pain rating scale presents a range of faces with a happy face associated with a score of 0, meaning "no hurt", to a very sad face associated with a score of 10, meaning "hurts worst."
Measured: From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-thickness Burn WoundsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention study model is a split-body intervention in which each patient has part of their burn treated with intact fish skin graft and another part treated with autograft as the standard-of-care.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Burn Association, BData, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326657
- Sponsor's protocol ID
- KS-1040
- Acronym
- LOGI
- Status last verified
- Jan 2026
- First submitted
- 3 Jun 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Controlled, Randomized, Multicenter Study Evaluating Intact Fish Skin Graft in Promoting AutoLOgous Skin Tissue ReGeneratIon of Deep Partial-Thickness Burns: The LOGI Study
- ClinicalTrials.gov ID
- NCT07326657
- Acronym / sponsor ID
- LOGI / KS-1040
- Conditions
- Partial-thickness Burn Wounds
- Keywords
- burn, deep partial-thickness, Kerecis, fish skin graft, autograft, split thickness skin graft, fish skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- American Burn Association, BData, Inc.
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Jan 2026 (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 goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft treatment is clinically indicated. This clinical trial seeks to collect the following:
- Difference in the percentage area of the IFSG treatment site and control autograft treatment site that required autografting within 1 month of treatment
- Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment
- Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment
- Difference in the pain intensity between the IFSG treatment site and autograft treatment site
Each participant will receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn. Participants will be assessed for the need for further autograft treatment. Participants will also be assessed for wound closure, pain, and cosmesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention study model is a split-body intervention in which each patient has part of their burn treated with intact fish skin graft and another part treated with autograft as the standard-of-care.
| Arm | Type | Receives |
|---|---|---|
| IFSG-Treated Area of Burn | Experimental | Device: Intact fish skin graftThe area of the deep partial-thickness burn that is treated with IFSG |
| SOC Autograft-Treated Area of Burn | Active comparator | Procedure: autograftThe area of the deep partial-thickness burn that is treated with autograft as standard-of-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age at time of consent
- Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated.
- Be able to provide written informed consent or have a legally authorized representative
- Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting.
- Investigator expects that the donor site will heal without grafting
Key exclusion criteria (14 listed)
- Known allergy or hypersensitivity to fish (shellfish allergy is OK)
- Female who is actively pregnant or currently breast-feeding
- Vulnerable populations
- Currently receiving systemic immunosuppressive therapy
- Current or known history of malignancy or receipt of chemotherapy
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 |
|---|---|---|
| Intact fish skin graftTreatment with IFSG | Device | IFSG-Treated Area of Burn |
| autograftTreatment with autograft | Procedure or surgery | SOC Autograft-Treated Area of Burn |
Primary outcome
Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.
Time frame: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later
3 secondary outcomes
Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement
Time frame: From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later
Difference in cosmesis between the IFSG treatment site and autograft treatment site at Month 12 based on observer POSAS total score
Time frame: From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later
Difference in the pain intensity between the IFSG treatment site and autograft treatment site one week after treatment based on the Wong-Baker FACES pain rating scale (FPRS)
Time frame: From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later
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 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Partial-thickness Burn Wounds
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
RecruitingPhase 3
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Burns
Active, not recruitingPhase 2
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
Burns
Not yet recruiting
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
Burn, Burn Contracture of Skin
Not yet recruitingObservational study
Cell Suspension With Biologic Dressing for Burn Wounds
Wound Healing
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intact fish skin graft and autograft in people with Partial-thickness Burn Wounds, run by Kerecis Ltd. 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 13 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month. (time frame: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later). 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 8 Jan 2026.