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Clinical Trials in the USA / NCT05898698
Active, not recruiting Observational

Prospective Case Registry for Wounds

NCT05898698 · tracked via the Priya Life Science USA tracker
Sponsor
Kerecis Ltd
Phase
Observational
Started
2023-03-17
Last updated
2024-12-30

Condition(s) studied

Wound Healing Delayed

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Primary Endpoint : Complete Wound Closure — 32 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
Kerecis Arlington Virginia

More Kerecis Ltd. trials in the USA

Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement Active, not recruiting
Evaluating the Durability of Closure for Venous Leg Ulcers Recruiting
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers Recruiting
AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF Active, not recruiting
Omega3 Wound Fish Skin Graft in the Treatment of DFUs Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05898698 on ClinicalTrials.gov ↗ ← All trials in the USA