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CompletedNCT02464982Updated Apr 13, 2016

Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer

An observational study in Breast Cancer, Right or Left Breast Mammary Reconstruction and Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
107
Sex
Female
01

Study summary

Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.

The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

Read the detailed description

Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :

  • Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
  • Evaluate from patient and jury, the tall, form, color and areola position defects
  • Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria
02

Conditions studied

  • Breast Cancer
  • Right or Left Breast Mammary Reconstruction
  • Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 107 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with 1 year non-invasive technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer.

Inclusion criteria

  • technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer

Exclusion criteria

Exclusion Criteria:

  • Two breasts operated patient
  • surgical reconstruction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
107 participants (actual)
Patient registry
No

Groups and cohorts

  • Women with 1 year non-invasive technology areola tattoo

    Women with 1 year non-invasive technology areola tattoo realized in standard care as part of 1 breast mammary reconstruction following an operated breast cancer

    Procedure: Tattoo

Interventions

  • ProcedureTattoo

    tattoo device with EC standards, and sterile single-use only needle

06

What researchers measure

Primary outcomes

  1. Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment

    Time frame: 1 year after areola tattoo have been realized following standard care

07

Study locations

1 site
  • esthetic, reconstruction and maxillo-facial surgery department, University Hospital
    Strasbourg, 67000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02464982
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Feb 2012
Primary completion
May 2015
Last update
Apr 13, 2016

Study contacts

Sylvie DUGUET
principal investigator · esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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