Prospective Case Registry for Wounds

Running, not enrolling

Conditions studied: Wound Healing Delayed

In brief

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.

Key facts

Study ID

NCT05898698

Run by

Kerecis Ltd.

People needed

300

Starts

2023-03-17

Expected to finish

2025-12-17

Last updated by the study team

2024-12-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Kerecis — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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