Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The patients will undergo breast reconstruction with an expander prosthesis.

The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis.

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

Autologous fat transplantation

breast reconstruction with expander prosthesis.

Expander prosthesis

Inkeri Schultz, PhD

Åsa Edsander-Nord, Docent

Marie Wickman Chantereau, Professor

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.

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.

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

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

Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis.

Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed.

Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients.

Breast Q is a validated questionnaire for quality of life

Karolinska University Hospital

Karolinska Institutet

Adjunct professor

Diseases and Abnormalities at or Before Birth

Carcinoma

Congenital Abnormalities

Carcinoma, Ductal

Carcinoma, Ductal, Breast

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.

ADRC-Enhanced Autologous Fat Transplant

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).

Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy	NCT00616135	Breast Neoplasm... Carcinoma, Duct... Mammaplasty Mastectomy, Seg...	ADRC-Enhanced A...	18 Years - 75 Years	Cytori Therapeutics

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