WoundsISACODNCT06384183
Kerecis Real-World Fish Skin Graft Registry
An observational study of Wounds and Pressure Ulcer, run by Kerecis Ltd. at 6 sites in United States.
Trial summary
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Kerecis Fish Skin Graft
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Aug 2024to Jun 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Investigators will only enter previously collected clinical data from patients (all ages, demographics, and any health status) who meet all inclusion criteria and no exclusion criteria.
Who may be able to join
- Provided informed consent
- Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Feet First Institute of Beavercreek
Beavercreek, Ohio, 45432
ABC Podiatry
Columbus, Ohio, 43213
Cone Health Ortho Care Greensboro
Greensboro, North Carolina, 27401
South Texas Skin Cancer Center
San Antonio, Texas, 78215
MCR Health
Sarasota, Florida, 34237
University Park
Sarasota, Florida, 34243
About this study
Official title: Kerecis Real-World Fish Skin Graft Registry - "ISACOD"
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
Read the detailed description
This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound, Soft Tissue Reinforcement
- Being tested
- Kerecis Fish Skin Graft
- Medical subject headings
- Wounds and Injuries, Pressure Ulcer, Diabetic Foot, Varicose Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis Fish Skin GraftDevice
Patients already treated with a Kerecis device
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. Receives: Device: Kerecis Fish Skin Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fish Skin Graft Device Related failure
Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)
Measured: 12 months
Fish Skin Graft Device related allergy
Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development)
Measured: 12 months
Target Wound Infection
Proportion of patients who develop target wound infection
Measured: 12 months
Secondary outcomes (2)
Complete Wound Healing
The Time in weeks to complete healing
Measured: 12 months
Complete Wound Closure
Proportion of participants who experience complete wound closure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start7 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Swearingen, Principal investigator, Kerecis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384183
- Sponsor's protocol ID
- KS-1000
- Acronym
- ISACOD
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kerecis Real-World Fish Skin Graft Registry - "ISACOD"
- ClinicalTrials.gov ID
- NCT06384183
- Acronym / sponsor ID
- ISACOD / KS-1000
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound, Soft Tissue Reinforcement
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
Detailed description
This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Device: Kerecis Fish Skin GraftThis observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Investigators will only enter previously collected clinical data from patients (all ages, demographics, and any health status) who meet all inclusion criteria and no exclusion criteria.
Key inclusion criteria (2 listed)
- Provided informed consent
- Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Kerecis Fish Skin GraftPatients already treated with a Kerecis device | Device | Observational Group |
Primary outcome
Fish Skin Graft Device Related failure
Time frame: 12 months
Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)
Fish Skin Graft Device related allergy
Time frame: 12 months
Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development)
Target Wound Infection
Time frame: 12 months
Proportion of patients who develop target wound infection
2 secondary outcomes
Complete Wound Healing
Time frame: 12 months
Complete Wound Closure
Time frame: 12 months
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 30 Dec 2024.
- Individual participant dataSharing planned: Undecided. To be determined
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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.
Anne Swearingen principal investigator
Kerecis Ltd.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Pressure Ulcer, run by Kerecis Ltd. at 6 sites 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 2 inclusion and 1 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Fish Skin Graft Device Related failure (time frame: 12 months). The study lists 3 primary outcomes in all. 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 30 Dec 2024.