Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous fat transplantation | Procedure | — | UNRESOLVED |
| Expander prosthesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast reconstruction with implant
- description
- The patients will undergo breast reconstruction with an expander prosthesis.
- interventionNames
- Procedure: Expander prosthesis
- type
- EXPERIMENTAL
- label
- Autologous fat transplantation
- description
- The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis.
- interventionNames
- Procedure: Autologous fat transplantation
- Procedure: Expander prosthesis
Primary outcomes (2)
- measure
- Frequency of reoperations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDSerra-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
- BACKGROUNDRigotti 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
- BACKGROUNDSarfati 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
- BACKGROUNDMojallal 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