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Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures

NCT ID: NCT06036485

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-05-01

Brief Summary

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Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There is an increasing need for definitive treatment of especially chronic venous and multifactorial chronic leg ulceration where arterial intervention is not a treatment option.

Minimal invasive surgical interventions that do not require skin grafting can be performed under local anesthesia in an outpatient setting even in multimorbid patients.

Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat, protein, elastin, glycans and other natural skin elements and it can be an effective treatment option in chronic leg ulcerations and is licensed for this use as a medical product in Switzerland. However, limited data without inter-wound bias is available for the use of Kerecis Omega 3 in chronic leg ulcerations.

In this study the investigators propose to investigate the efficacy of Kerecis Omega 3 according to objective wound surface measurements using standardized digital photographs in patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care wound debridement.

Detailed Description

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Conditions

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Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 in-wound split design with random allocation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Kerecis Omega 3

Group Type EXPERIMENTAL

Kerecis Omega 3

Intervention Type DEVICE

Decellularized intact fish skin developed for the management of chronic wounds

Surgical debridement

Group Type ACTIVE_COMPARATOR

Surgical debridement

Intervention Type PROCEDURE

Superficial sharp surgical debridement technique

Interventions

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Kerecis Omega 3

Decellularized intact fish skin developed for the management of chronic wounds

Intervention Type DEVICE

Surgical debridement

Superficial sharp surgical debridement technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any chronic leg ulcer \> 4 weeks duration with delayed wound healing (reduction of wound surface of less than 40-50% within 4 weeks under adequate local therapy) without underlying treatable medical conditions
* Ulcer area at between 5cm2 and 60cm2
* Bacterial swab sampling prior to study
* Written study informed consent

Exclusion Criteria

* History of Fish allergy or proven Fish allergy
* Pregnant or breast-feeding women
* Intention to become pregnant during the course of the study
* Wound not suitable for dressing: inflammation, fibrin coatings
* Inability to understand the study consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Bossart, MD

Role: PRINCIPAL_INVESTIGATOR

Department of dermatology, University Hospital Inselspital, Bern

Other Identifiers

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Kerecis-1

Identifier Type: -

Identifier Source: org_study_id