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CompletedNCT03312166SCARWARSUpdated Sep 19, 2024

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

An interventional study of Compression device in Keloid, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.

02

Conditions studied

  • Keloid

Keywords

  • ear lobe
  • compression
  • medical device
  • recurrence
03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

This study's enrollment of 31 is close to the median of 30 across 109 interventional studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.

Browse Centre Hospitalier Universitaire de Besancon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient over 18 yo;
  • Patient with aer lobe keloid;
  • Patient with an indication of reconstructive surgery;
  • Signature of from the patient;
  • Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study;
  • Patient with French social insurance.

Exclusion criteria

Exclusion Criteria:

  • Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality);
  • Patient with know nickel allergy;
  • Patient with know silicon allergy;
  • Pregnant women;
  • Legal incapacity or limited legal capacity;
  • Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator;
  • Patient without health insurance;
  • The patient is in the period of exclusion of another study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Compression device

    Device: Compression device

Interventions

  • DeviceCompression device

    interventions on patient are : * surgical excision of ear lobe keloid * application of compression device on sutured skin

06

What researchers measure

Primary outcomes

  1. Recurrence of keloid scar

    Recurrence will be assessed during each visit by surgeon

    Time frame: 12 month

07

Study locations

1 site
  • CHU de Besançon
    Besançon, 25000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2023, 74 months.

Of 20 interventional studies with no phase under Keloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 74 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 17, 2017
StartActual
Oct 3, 2017
Primary completionActual
Dec 14, 2023
CompletionActual
Dec 14, 2023
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312166
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Oct 3, 2017
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Sep 19, 2024

Study contacts

Brice Chatelain, MD
principal investigator · Centre Hospitalier Universitaire de Besançon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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