- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464982
Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer
Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Strasbourg, France, 67000
- esthetic, reconstruction and maxillo-facial surgery department, University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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
|
tattoo device with EC standards, and sterile single-use only needle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year after areola tattoo have been realized following standard care
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sylvie DUGUET, esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRIP 2011 / 1 AMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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