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OpenTrials
Completed

NCT Number: NCT05286424

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

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.

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Key information

Conditions

The Impact of Adipose Tissue Quality on Fat Graft Retention

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fat Grafting

Procedure

Fat will be removed from abdomen or legs, processed and re-injected into grafting sites.

Other names: lipofilling

Primary outcomes

  1. Adipose tissue dependent take rate

    Time frame: 12-24 months

    Detect an adipose tissue composition-dependent take rate

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Joanneum Research Forschungsgesellschaft mbH

Registry information

Official study title

Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study

Acronym: LipoTech

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.