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NFC Dressing for Skin Graft Donor Sites

NCT03980600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-06-10

No results posted yet for this study

Summary

The aim of this single center clinical investigation was to optimize nanofibrillar cellulose (NFC) wound dressing and to investigate final product FibDex in the treatment of split thickness skin graft donor sites. Performance of NFC dressings Type 1, Type 2, Type 3 and Type 4 (final product, FibDex) was compared with that of Suprathel®.

Conditions

  • Skin Transplantation

Interventions

DEVICE

FibDex wound dressing

Treatment of donor sites of 24 patients with the dressing Type 4 (final product i.e. FibDex) until the self-detachment of the wound dressing i.e. epithelialization

DEVICE

NFC wound dressing Types 1-3

Treatment of donor sites of 9 patients with the NFC dressing's (proto)Types 1-3 until the self-detachment of the wound dressing i.e. epithelialization

DEVICE

Suprathel (comparator)

Treatment of donor sites of 22 patients with Suprathel dressing, which was used as a reference (comparator) product, until the self-detachment of the wound dressing i.e. epithelialization

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • UPM-Kymmene Corporation

    lead INDUSTRY

Principal Investigators

  • Jyrki Vuola, MD, PhD · Helsinki Burn Centre, Helsinki University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-16
Primary Completion
2018-01-08
Completion
2018-09-19

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 NCT03980600 on ClinicalTrials.gov