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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT02464982
• Collaborator: (none)
• Enrollment: 107
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Right or Left Breast Mammary Reconstruction; Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast	Procedure: Tattoo

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 Design

• Study Type: Observational
• Actual Enrollment: 107 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; tattoo device with EC standards, and sterile single-use only needle

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	esthetic, reconstruction and maxillo-facial surgery department, University Hospital	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Sylvie DUGUET, esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02464982
• Other Study ID Numbers: PHRIP 2011 / 1 AMC
• First Posted: Jun 8, 2015
• Last Update Posted: Apr 13, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Breast Neoplasms; Neoplasms

Study Results

No Results Posted as of Apr 13, 2016