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

Completed

• Conditions: Right or Left Breast Mammary Reconstruction; Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast; Breast Cancer
• Interventions: Procedure: Tattoo

• Registration Number: NCT02464982
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

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

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2015-05
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with 1 year non-invasive technology areola tattoo	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

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment	1 year after areola tattoo have been realized following standard care

Trial Locations

Locations (1)

esthetic, reconstruction and maxillo-facial surgery department, University Hospital; 🇫🇷 Strasbourg, France