Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures

Study Overview
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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.

Official Title
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Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: Kerecis Omega 3
* Procedure: Surgical debridement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 in-wound split design with random allocation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kerecis Omega 3<br> | Device: Kerecis Omega 3<br>* Decellularized intact fish skin developed for the management of chronic wounds<br>|
| Active Comparator: Surgical debridement<br> | Procedure: Surgical debridement<br>* Superficial sharp surgical debridement technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ulcer surface area | Change in ulcer surface area as assessed by standardized photography and digital imaging. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient quality of life | Change in patient quality of life as assessed by the Wound-QoL questionnaire score, ranging from 0 to 4, with higher scores indicating a worse quality of life. | 2, 4, 6 and 12 weeks | 
| Change in wound microbiota as assessed by alpha diversity of the microbial composition | Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by alpha diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species | 2, 4, 6 and 12 weeks | 
| Change in wound microbiota as assessed by beta diversity of the microbial composition | Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by beta diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species. | 2, 4, 6 and 12 weeks | 
| Change in ulcer surface area | Change in ulcer surface area as assessed by standardized photography and digital imaging. | 2, 4, 6 and 12 weeks |