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Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures

NCT06036485 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-06

No results posted yet for this study

Summary

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.

Conditions

  • Leg Ulcer

Interventions

DEVICE

Kerecis Omega 3

Decellularized intact fish skin developed for the management of chronic wounds

PROCEDURE

Surgical debridement

Superficial sharp surgical debridement technique

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Simon Bossart, MD · Department of dermatology, University Hospital Inselspital, Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-05-01
Completion
2023-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036485 on ClinicalTrials.gov