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Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)

NCT05666999 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-15

No results posted yet for this study

Summary

FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds and to compare clinical performance and safety of FibDex® to current clinical practice.

Conditions

  • Skin Transplantation

Interventions

DEVICE

FibDex®

To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.

DEVICE

Suprathel

To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.

DEVICE

Aquacel Foam

To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • UPM-Kymmene Corporation

    lead INDUSTRY

Principal Investigators

  • Kari Luukko, Dr.Tech · Director, Quality Assurance

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Finland

Study Locations

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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 NCT05666999 on ClinicalTrials.gov