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

April 15, 2019 updated by: Marie Wickman Chantereau, Karolinska Institutet

Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.

Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.

Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.

After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska Institutet, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Department of Reconstructive Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Previously undergone mastectomy and adjuvant radiotherapy.
  • Will undergo breast reconstruction with expander prosthesis.
  • Mammogram and ultrasound performed maximum three month prior surgery.
  • At least one year since last operation or radiotherapy.

Exclusion Criteria:

  • Known breast cancer relapse
  • Distant metastases except axillary
  • Any contraindication for anaesthesia
  • Systemic disease such as diabetes mellitus type I.
  • BMI >30 (if the patients lose weight they are eligible)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast reconstruction with implant
The patients will undergo breast reconstruction with an expander prosthesis.
Procedure: Expander prosthesis
breast reconstruction with expander prosthesis.
Other Names:
  • implant
Experimental: Autologous fat transplantation
The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis.
Procedure: Expander prosthesis
breast reconstruction with expander prosthesis.
Other Names:
  • implant
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.
Other Names:
  • lipofilling
  • fat grafting
  • lipomodelling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of reoperations
Time Frame: Two years on from reconstruction with prosthesis
Two years on from reconstruction with prosthesis
Frequency of complications
Time Frame: Two years on from reconstruction with prosthesis
Two years on from reconstruction with prosthesis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total days in hospital during fat transplantation and reconstruction with prosthesis
Time Frame: 4 month
Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis.
4 month
Number of appointments as outpatient after breast reconstruction.
Time Frame: Two years on from reconstruction with prosthesis
Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed.
Two years on from reconstruction with prosthesis
Aesthetic evaluation of the results of the breast reconstruction
Time Frame: Two years on from reconstruction with prosthesis
Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients.
Two years on from reconstruction with prosthesis
Patient reported outcome
Time Frame: Measured at 6, 12 and 24 month from reconstruction with prosthesis
Breast Q is a validated questionnaire for quality of life
Measured at 6, 12 and 24 month from reconstruction with prosthesis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Study Chair: Inkeri Schultz, PhD
  • Study Chair: Åsa Edsander-Nord, Docent
  • Study Director: Marie Wickman Chantereau, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTLIP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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