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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02637635
• Other study ID #: RCTLIP1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: January 2020

Study information

• Verified date: April 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.
• Expander prosthesis
breast reconstruction with expander prosthesis.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Department of Reconstructive Plastic Surgery	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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):765-74. doi: 10.1097/PRS.0b013e3181b17b8f. — View Citation

Rigotti G, Marchi A, Galiè 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):1409-22; discussion 1423-4. — View 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. — View Citation

Serra-Renom JM, Muñoz-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):12-8. doi: 10.1097/PRS.0b013e3181c49458. — View Citation

Outcome

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

External Links

•   Swedish Breast Cancer Group. Provides national guidelines for breast cancer treatment etc.