Skip to main content
OpenTrials
Completed

NCT Number: NCT02464982

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast Neoplasms Neoplasms by Site Right or Left Breast Mammary Reconstruction Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

esthetic, reconstruction and maxillo-facial surgery department, University Hospital

Strasbourg, 67000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Two breasts operated patient
  • surgical reconstruction

Treatment and study plan

Tattoo

Procedure

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology

Important dates

Study start
2012
Primary completion
2015
First posted
Jun 8, 2015
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.