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Spots Global Cancer Trial Database for Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

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Trial Identification

Brief Title: 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 ID: NCT02637635

Study Description

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

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Inkeri Schultz, PhD

Affiliation:

Role: STUDY_CHAIR

Name: Åsa Edsander-Nord, Docent

Affiliation:

Role: STUDY_CHAIR

Name: Marie Wickman Chantereau, Professor

Affiliation:

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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