NCT05898698

Active Not Recruiting

Prospective Case Registry for Wounds

Kerecis Ltd.Source

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Other study identifiers

Sponsor study identifier

KS-0790

Study Type

observational

Estimated enrollment

300

Locations

1 country

Sites

1

Timeline

Study Start

March 17, 2023

Actual (reported)

Primary Completion

March 17, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 17, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

This is a post-market, observational and non-interventional registry to collect real-world data in diverse clinical settings and wound applications of acellular fish skin graft (FSG). The registry will be multi-center , target a wide patient population and a variety of wounds to document the quality of wound care, patient outcomes, safety and long-term results.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 300 participants
Study completion date: December 17, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 17, 2023
Actual (reported)
First Submitted
June 1, 2023
Actual (reported)
First Posted
June 12, 2023
Actual (reported)
Primary Completion
March 17, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 17, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 30, 2024
Status Verified: October 2024
Last Update Submitted: December 27, 2024

Conditions

Wound Healing Delayed

Outcome Measures

Primary Outcomes (1)

Primary Endpoint : Complete Wound Closure
Is time and frequency of complete wound closure by or on 32 weeks. Complete closure is referred to as full epithelialization with the absence of drainage.
32 weeks

Secondary Outcomes (7)

Secondary Endpoints : Reduction in wound area
32 weeks
Reduction in wound depth
32 weeks
Increase in Vascularization
32 weeks
Pain medication use
32 weeks
Number of applications/Cost
32 weeks
+2 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Ages above 18 less than 90 years of age who have wounds being treated with FSG.

You may qualify if:

Subjects age 18 and older and are able to provide informed consent.

Sponsors & Collaborators

Kerecis Ltd.
Industrylead

Study Sites (1)

Kerecis

Arlington, Virginia, 22201, United States

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Target Duration: 1 Year
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

March 17, 2023

Actual (reported)

Primary Completion

March 17, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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Having at least one partial or full thickness wound appropriate for FSG and the wound has NOT received FSG previously.

Appropriate wounds include: Partial or full thickness wounds, Diabetic foot ulcers, venous leg ulcers, pressure ulcers, chronic vascular ulcers, Trauma wounds (2nd degree burn, abrasions, lacerations, skin tears.

Surgical wounds (donor sites/grafts, post-Mohs surgery, post Laser surgery, podiatric, wound dehiscence

You may not qualify if:

Patient has a 3rd degree burn Patient has a know sensitivity to fish products Patient whose target wound was previously treated with FSG Patient is breastfeeding

Contact the study team to confirm eligibility.

Study Completion

December 17, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05898698
Data provider: ClinicalTrials.gov
Source updated: 2024-12-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:11 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations