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

NCT ID: NCT05286424

Last Updated: 2022-08-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Impact of Adipose Tissue Quality on Fat Graft Retention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fat grafting

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lipofilling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Joanneum Research Forschungsgesellschaft mbH

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medizinische Universität Graz

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

32-487 ex 19/20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.