Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Adipose tissue dependent take rate
Study Overview
Brief Summary
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.
The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.
The study was registered on Clinicaltrials.gov after start of recruitment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
- •History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
- •Planned, elective breast-lipofilling
- •Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
- •Currently healthy individual, willing to participate in this study
Exclusion Criteria
- •Previous surgery at the harvesting site (e.g. caesarian section)
- •Pregnancy or planned pregnancy
- •Current or preceded chemotherapy
- •Preceded radiatio
- •Unable to fully understand study procedures and to provide informed consent
Outcomes
Primary Outcomes
Adipose tissue dependent take rate
Time Frame: 12-24 months
Detect an adipose tissue composition-dependent take rate
Secondary Outcomes
No secondary outcomes reported