NCT05898698

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2025

Completed
Last Updated

December 30, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

June 1, 2023

Last Update Submit

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.
  • 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.

Sponsors & Collaborators

Study Sites (1)

Kerecis

Arlington, Virginia, 22201, United States

Location

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

Primary Completion

March 17, 2025

Study Completion

December 17, 2025

Last Updated

December 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)