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Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery (LipoTech)

M

Medical University of Graz

Status

Completed

Conditions

The Impact of Adipose Tissue Quality on Fat Graft Retention

Treatments

Procedure: fat grafting

Study type

Interventional

Funder types

Other

Identifiers

NCT05286424
32-487 ex 19/20

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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