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

NCT ID: NCT05666999

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-04-30

Brief 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.

Detailed Description

STSG is a reconstructive procedure that is most used for management of burn injuries. Skin harvesting creates a new partial thickness wound, a donor site that causes additional pain for the patient during the postoperative recovery. Therefore, and because wound healing complications, such as delayed healing and infections, are common donor sites, the donor sites are problematic to treat. A dressing that wound provide optimal healing, low costs, and minimal pain with few dressing changes would be a preferred choice for treatment of donor sites. NFC wound dress, like FibDex, are used for providing these kinds of benefits to patients and better healing result.

This is a sponsored prospective, randomized, controlled, non-blinded, non-inferiority study. Subjects will be treated with the IMD or the comparator and act as their own controls. Subjects will be followed up for up to POD 365. Purpose of this PMCF study for FibDex is to gather data for updating the clinical evaluation and assess if new data gained over time has a bearing on the risk-benefit assessment or if there are some needs to make changes to the product or the package. Clinical evaluation is ongoing and happens throughout the medical devices lifetime. Clinical safety need to be analyzed periodically according to MDR requirements. For class IIb products, like FibDex, it means clinical safety update every year. This study is part of that evaluation.

Aim is to get 48 randomized STSG wounds. Study methods during this study are using the IMD or the comparator after the surgery, subject diaries, pain questionnaires, scar quality assessments by investigator and study subjects and visual observation by the delegated site staff. Also, photos of the healing process will be collected.

Conditions

Skin Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

FibDex

IMD

Group Type: OTHER

FibDex®

Intervention Type: DEVICE

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.

Suprathel

Primary Comparator.

Group Type: ACTIVE_COMPARATOR

Suprathel

Intervention Type: DEVICE

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.

Aquacel Foam

Secondary Comparator.

Group Type: ACTIVE_COMPARATOR

Aquacel Foam

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects aged at least 18 years when signing the informed consent

2. Subjects with wounds that need split thickness skin grafting (STSG)

3. Subjects that have at least one STSG donor site wound at least 5 x 5 cm and maximum 20 x 30 cm or two STSG donor site wounds of same size, at least 5 x 5 cm and maximum 20 x 30 cm, anatomically close to each other or on anatomically similar area in the opposite extremity or body area.

Exclusion Criteria

1. Subjects allergic to, or have had an allergic reaction to IMDs components (wood cellulose and polypropylene) or the comparator's components (polylactic acid-based copolymer or natrium carboxymethylcellulose)

2. Pregnant or breast-feeding women

3. Subjects with solid organ transplantation

4. Any other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusion

5. Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency)

6. STSG donor site wound(s) on sensitive skin areas, such as the facial area, the genital area or mucous membranes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

UPM-Kymmene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Luukko, Dr.Tech

Role: STUDY_DIRECTOR

Director, Quality Assurance

Locations

Helsinki University Hospital

Espoo, Uusimaa, Finland

Countries

Finland

Other Identifiers

FibDex 2-2022

Identifier Type: -

Identifier Source: org_study_id