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

NCT ID: NCT02464982

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Tattoo

Intervention Type PROCEDURE

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

Interventions

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Tattoo

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie DUGUET

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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PHRIP 2011 / 1 AMC

Identifier Type: -

Identifier Source: org_study_id

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