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

NCT02637635 | Unknown

• 1 other identifier: RCTLIP1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 1.To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
2. 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.

Conditions

Breast Neoplasms

Keywords

Mammaplasty; Transplantation, Autologous; Mastectomy; Breast Implants; Radiotherapy, Adjuvant

Outcome Measures

Primary Outcomes (2)

• Frequency of reoperations

  Two years on from reconstruction with prosthesis

• Frequency of complications

  Two years on from reconstruction with prosthesis

Secondary Outcomes (4)

• Total days in hospital during fat transplantation and reconstruction with prosthesis

  4 month

• Number of appointments as outpatient after breast reconstruction.

  Two years on from reconstruction with prosthesis

• Aesthetic evaluation of the results of the breast reconstruction

  Two years on from reconstruction with prosthesis

• Patient reported outcome

  Measured at 6, 12 and 24 month from reconstruction with prosthesis

Study Arms (2)

Breast reconstruction with implant

EXPERIMENTAL

The patients will undergo breast reconstruction with an expander prosthesis.

Procedure: Expander prosthesis

Autologous fat transplantation

EXPERIMENTAL

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

Procedure: Autologous fat transplantation; Procedure: Expander prosthesis

Interventions

Autologous fat transplantation PROCEDURE

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

Also known as: lipofilling, fat grafting, lipomodelling

Autologous fat transplantation

Expander prosthesis PROCEDURE

breast reconstruction with expander prosthesis.

Also known as: implant

Autologous fat transplantation; Breast reconstruction with implant

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

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

Stockholm, 17177, Sweden

Location

Related Publications (4)

• 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.

  PMID: 20048576 BACKGROUND

• 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.

  PMID: 17415234 BACKGROUND

• 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.

  PMID: 21514910 BACKGROUND

• 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.

  PMID: 19730294 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Inkeri Schultz, PhD

  STUDY CHAIR

• Åsa Edsander-Nord, Docent

  STUDY CHAIR

• Marie Wickman Chantereau, Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 22, 2015
• Study Start: October 1, 2012
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

SE (1)