NCT05286424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

March 9, 2022

Last Update Submit

August 24, 2022

Conditions

The Impact of Adipose Tissue Quality on Fat Graft Retention

Keywords

fat graft, adipose tissue

Outcome Measures

Primary Outcomes (1)

  • Adipose tissue dependent take rate

    Detect an adipose tissue composition-dependent take rate

    12-24 months

Interventions

fat graftingPROCEDURE

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

Also known as: lipofilling

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFat grafting after mastecomy is studied, therefore a gender bias is not avoidable.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Universität Graz

Graz, 8036, Austria

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

February 15, 2021

Primary Completion

July 28, 2021

Study Completion

July 10, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

AU(1)