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

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ClinicalTrials.gov Identifier: NCT02637635
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Marie Wickman Chantereau, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Autologous fat transplantation Procedure: Expander prosthesis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study
Study Start Date : October 2012
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 Name: 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: 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

Procedure: Expander prosthesis
breast reconstruction with expander prosthesis.
Other Name: implant




Primary Outcome Measures :
  1. Frequency of reoperations [ Time Frame: Two years on from reconstruction with prosthesis ]
  2. Frequency of complications [ Time Frame: Two years on from reconstruction with prosthesis ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Quality of life [ Time Frame: Measured at 6, 12 and 24 month from reconstruction with prosthesis ]
    Breast Q is a validated questionnaire for quality of life

  5. Breast symmetry [ Time Frame: Measured at 6, 12 and 24 month from reconstruction with prosthesis ]
    Standardized measurements of breast symmetry will be performed



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637635


Contacts
Contact: Anna Lindegren, PhD Student 0046707124146 anna.lindegren@ki.se
Contact: Marie Wickman Chantereau, Professor 00468517 700 00 marie.wickman‑chantereau@karolinska.se

Locations
Sweden
Karolinska Institutet, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Department of Reconstructive Plastic Surgery Recruiting
Stockholm, Sweden, 17177
Contact: Anna Lindegren, PhD Student    0046707124146    anna.lindegren@ki.se   
Contact: Marie Wickman Chantereau, Professor    0046851770000    marie.wickman‑chantereau@karolinska.se   
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
Study Chair: Inkeri Schultz, PhD
Study Chair: Åsa Edsander-Nord, Docent
Study Director: Marie Wickman Chantereau, Professor

Additional Information:
Publications:
Responsible Party: Marie Wickman Chantereau, Adjunct professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02637635     History of Changes
Other Study ID Numbers: RCTLIP1
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Marie Wickman Chantereau, Karolinska Institutet:
Mammaplasty
Transplantation, Autologous
Mastectomy
Breast Implants
Radiotherapy, Adjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases