Clinical trial NCT02637635: Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Mammaplasty
Transplantation, Autologous
Mastectomy
Breast Implants
Radiotherapy, Adjuvant
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2015-12-22
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Frequency of reoperations
timeFrame: Two years on from reconstruction with prosthesis
measure: Frequency of complications
timeFrame: Two years on from reconstruction with prosthesis
Secondary outcomes:
measure: Total days in hospital during fat transplantation and reconstruction with prosthesis
timeFrame: 4 month
measure: Number of appointments as outpatient after breast reconstruction.
timeFrame: Two years on from reconstruction with prosthesis
measure: Aesthetic evaluation of the results of the breast reconstruction
timeFrame: Two years on from reconstruction with prosthesis
measure: Patient reported outcome
timeFrame: Measured at 6, 12 and 24 month from reconstruction with prosthesis
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Department of Reconstructive Plastic Surgery
Study officials:
name: Inkeri Schultz, PhD
role: STUDY_CHAIR
name: Åsa Edsander-Nord, Docent
role: STUDY_CHAIR
name: Marie Wickman Chantereau, Professor
role: STUDY_DIRECTOR
References:
citation: Serra-Renom JM, Munoz-Olmo JL, Serra-Mestre JM. Fat grafting in postmastectomy breast reconstruction with expanders and prostheses in patients who have received radiotherapy: formation of new subcutaneous tissue. Plast Reconstr Surg. 2010 Jan;125(1):12-18. doi: 10.1097/PRS.0b013e3181c49458.
citation: Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.
citation: Sarfati I, Ihrai T, Kaufman G, Nos C, Clough KB. Adipose-tissue grafting to the post-mastectomy irradiated chest wall: preparing the ground for implant reconstruction. J Plast Reconstr Aesthet Surg. 2011 Sep;64(9):1161-6. doi: 10.1016/j.bjps.2011.03.031. Epub 2011 Apr 22.
citation: Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.