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Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

NCT02637635 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-04-17

No results posted yet for this study

Summary

The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.

Our aims are:

1. To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
2. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

Conditions

  • Breast Neoplasms

Interventions

PROCEDURE

Autologous fat transplantation

100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.

PROCEDURE

Expander prosthesis

breast reconstruction with expander prosthesis.

Sponsors & Collaborators

Principal Investigators

  • Inkeri Schultz, PhD

  • Åsa Edsander-Nord, Docent

  • Marie Wickman Chantereau, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637635 on ClinicalTrials.gov