NCT03980600

Brief 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®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

May 23, 2019

Last Update Submit

June 7, 2019

Conditions

Skin Transplantation

Outcome Measures

Primary Outcomes (2)

  • Wound healing time

    The healing time of the donor site was determined as the self-detachment day of the dressing that was checked by visual observation at interval of a few days until self-detachment.

    Postoperative day (POD) as a checkpoint :14 days

  • Wound healing time

    The healing time of the donor site was determined as the self-detachment day

    Postoperative day (POD) as a checkpoint: 1 month

Secondary Outcomes (6)

  • Subjective pain

    On postoperative day (POD) 10-15, 1 month and 6 months review

  • Epithelialization

    Postoperative day (POD) 14, 1 month, 6 months

  • Scar quality

    1 month and 6 months postoperatively

  • Skin elasticity

    1 month and 6 months postoperatively

  • Transepidermal water loss (TEWL)

    1 month and 6 months postoperatively

  • +1 more secondary outcomes

Study Arms (1)

Donor site treatment with NFC dressing/FibDex®

EXPERIMENTAL

Patients requiring skin graft donor site treatment were enrolled in the investigation. Patients were selected based on clinical evaluation by a plastic surgeon. Of the total 33 patients enrolled in the study, nine patients were treated during the optimization phase with experimental NFC dressing Types 1-3. The remaining 24 patients were treated with the final product Type 4 (FibDex®). The mean age of patients treated with NFC dressing/FibDex® was 50 ± 18 years, in the range of 21-74 years. Suprathel® was used to treat donor sites in the same patients as a reference material. During the optimization phase, Suprathel was intra-individually compared with NFC dressing types 1-3 in five patients out of nine. From the remaining 24 patients, Suprathel was intra-individually compared with FibDex® in 17 patients.

Device: FibDex wound dressingDevice: NFC wound dressing Types 1-3Device: Suprathel (comparator)

Interventions

FibDex wound dressingDEVICE

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

Also known as: NFC wound dressing
Donor site treatment with NFC dressing/FibDex®
NFC wound dressing Types 1-3DEVICE

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

Donor site treatment with NFC dressing/FibDex®
Suprathel (comparator)DEVICE

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

Donor site treatment with NFC dressing/FibDex®

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients with a need of skin graft donor site treatment under 10 % of the total body area

You may not qualify if:

  • Pregnancy
  • Age under 18
  • Age over 75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki Burn Centre, Department of Plastic Surgery, Helsinki University Hospital

Espoo, FI-00029, Finland

Location

Study Officials

  • Jyrki Vuola, MD, PhD

    Helsinki Burn Centre, Helsinki University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single center clinical investigation with patients selected by the clinicians. The donor sites were treated and compared intra-individually in the same patients.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 10, 2019

Study Start

February 16, 2015

Primary Completion

January 8, 2018

Study Completion

September 19, 2018

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)