NCT05666999

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

September 12, 2022

Last Update Submit

August 11, 2025

Conditions

Skin Transplantation

Keywords

Skin TransplantationDonor siteSTSGFibDex

Outcome Measures

Primary Outcomes (2)

  • Wound healing

    Wound healing percentage (%) is evaluated by the investigator on POD 21 by removing the dressing and assessing the epithelization.

    Post operative day 21

  • Wound healing

    Wound healing percentage (%) is evaluated by the investigator

    between post operative day 28-42, if not healed in 3 weeks

Secondary Outcomes (7)

  • Subject pain

    Diary for post operative days 0 to 21, NRS-scale 1 year.

  • Epithelialization percentage

    post operative day 21

  • Scar quality

    day 365

  • Scar quality

    1 year

  • Adverse events

    1 year

  • +2 more secondary outcomes

Study Arms (3)

FibDex

OTHER

IMD

Device: FibDex®

Suprathel

ACTIVE COMPARATOR

Primary Comparator.

Device: Suprathel

Aquacel Foam

ACTIVE COMPARATOR

Secondary Comparator.

Device: Aquacel Foam

Interventions

FibDex®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.

FibDex
SuprathelDEVICE

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
Aquacel FoamDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged at least 18 years when signing the informed consent
  • Subjects with wounds that need split thickness skin grafting (STSG)
  • 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.

You may not qualify if:

  • 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)
  • Pregnant or breast-feeding women
  • Subjects with solid organ transplantation
  • Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency)
  • STSG donor site wound(s) on sensitive skin areas, such as the facial area, the genital area or mucous membranes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Espoo, Uusimaa, Finland

Location

Study Officials

  • Kari Luukko, Dr.Tech

    Director, Quality Assurance

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The subjects will be randomized by using a sealed envelope system.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

December 28, 2022

Study Start

May 15, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)