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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464982
• Other study ID #: PHRIP 2011 / 1 AMC
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: April 12, 2016
• Start date: February 2012

Study information

• Verified date: April 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Tattoo
tattoo device with EC standards, and sterile single-use only needle

Locations

Country	Name	City	State
France	esthetic, reconstruction and maxillo-facial surgery department, University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No