NCT04884789

Brief Summary

The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
27mo left

Started Jan 2025

Longer than P75 for not_applicable

Status
withdrawn

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

Study Progress39%
Jan 2025Jul 2028

First Submitted

Initial submission to the registry

February 25, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
3.6 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

February 25, 2021

Last Update Submit

March 5, 2025

Conditions

Burn Scar

Keywords

BurnsTransparent Face OrthosisSilicone application3d PrintedFace

Outcome Measures

Primary Outcomes (1)

  • Number of Local Side Effects

    wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation

    Month 1

Secondary Outcomes (8)

  • Evaluation of scar evolution with VSS

    Month 1; Month 6; Month 12; Month 18; Month 24

  • Evaluation of scar evolution with POSAS

    Month 1; Month 6; Month 12; Month 18; Month 24

  • Wearing time

    Month 1; Month 6; Month 12; Month 18; Month 24

  • Manufacturing time

    Month 1; Month 6; Month 12; Month 18; Month 24

  • Reprints

    Month 1; Month 6; Month 12; Month18; Month 24

  • +3 more secondary outcomes

Study Arms (1)

Post-Burn Face scar

EXPERIMENTAL

Use of 3d printed TFO with silicone interface (COFIS 3D)

Device: COFIS 3D

Interventions

COFIS 3DDEVICE

Patient have to wear the COFIS 3D 20h a day for at least 6 month

Also known as: 3d printed Transparent Face Orthosis with silicone interface
Post-Burn Face scar

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Post-Burn Face scar during maturation stage or surgical intervention on post-burn face scar during maturation stage
  • Patient agrees to shave beard if necessary for 3D camera measurement
  • Patient able to express informed consent
  • Affiliation to a social security scheme

You may not qualify if:

  • Post burn face scar in the sequela stage
  • Patient with unbalanced photosensitive epilepsy
  • Patient with an unconsolidated fracture of the face's bones or skull
  • Patient with a known allergy to silicone
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BurnsFacies

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clémence DEFFINIS, MD

    CHR Metz Thionville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

May 13, 2021

Study Start

January 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

March 7, 2025

Record last verified: 2025-02