Volumetric Study of Fat Resorption After Breast Lipofilling
NCT ID: NCT03016663
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2015-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
NCT06147661
The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
NCT03197103
Breast Fat Grafting Augmentation in Chinese Women
NCT02551939
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
NCT05286424
The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction
NCT05424666
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breast Lipofilling Technique
Preliminary MRI breast were performed for volumetric measurement. Fat harvesting performed by same surgeon using water-assisted liposuction (WAL) and subsequent washing with buffered lactate in a standardized technique. Fat transfer performed using Berlin autologous lipotransplantation technique according to the BEAULI protocol .Patient were followed up monthly and MRI breast were repeated at 1st and 6th months after lipofilling. Clinical assessment and MRI Volumetric measurement performed using OsiriX (v7.0.3, 64 bit, Pixmeo c) software by same radiologist based on predefined operational procedure
Technique of Breast Lipofilling
1. Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker.
2. Fat Harvesting Berlin autologous lipotransplantation technique used according to the BEAULI protocol described by Ueberreiter et al.
Infiltration solution -"Klein'solution" contains 1 cc of epinephrine (1:500,000) diluted in 500 cc of 0.001% lactate ringer solution (LRS).
3. Fat Processing After aspiration of nonviable components of the aspirate, fat graft washed using Lactate Ringer Solution for three times. The fat processing and washing were performed by the same assistant for all patients.
4. Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn. Periglandular planes and intrapectoral planes are used. Intraparenchymal injection avoided.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Technique of Breast Lipofilling
1. Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker.
2. Fat Harvesting Berlin autologous lipotransplantation technique used according to the BEAULI protocol described by Ueberreiter et al.
Infiltration solution -"Klein'solution" contains 1 cc of epinephrine (1:500,000) diluted in 500 cc of 0.001% lactate ringer solution (LRS).
3. Fat Processing After aspiration of nonviable components of the aspirate, fat graft washed using Lactate Ringer Solution for three times. The fat processing and washing were performed by the same assistant for all patients.
4. Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn. Periglandular planes and intrapectoral planes are used. Intraparenchymal injection avoided.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Malaya
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alizan ABDUL KHALIL
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery University Malaya Medical Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fiaschetti V, Pistolese CA, Fornari M, Liberto V, Cama V, Gentile P, Floris M, Floris R, Cervelli V, Simonetti G. Magnetic resonance imaging and ultrasound evaluation after breast autologous fat grafting combined with platelet-rich plasma. Plast Reconstr Surg. 2013 Oct;132(4):498e-509e. doi: 10.1097/PRS.0b013e3182a00e57.
Agha RA, Goodacre T, Orgill DP. Use of autologous fat grafting for reconstruction postmastectomy and breast conserving surgery: a systematic review protocol. BMJ Open. 2013 Oct 22;3(10):e003709. doi: 10.1136/bmjopen-2013-003709.
Petit JY, Lohsiriwat V, Clough KB, Sarfati I, Ihrai T, Rietjens M, Veronesi P, Rossetto F, Scevola A, Delay E. The oncologic outcome and immediate surgical complications of lipofilling in breast cancer patients: a multicenter study--Milan-Paris-Lyon experience of 646 lipofilling procedures. Plast Reconstr Surg. 2011 Aug;128(2):341-346. doi: 10.1097/PRS.0b013e31821e713c.
Claro F Jr, Figueiredo JC, Zampar AG, Pinto-Neto AM. Applicability and safety of autologous fat for reconstruction of the breast. Br J Surg. 2012 Jun;99(6):768-80. doi: 10.1002/bjs.8722. Epub 2012 Apr 4.
Sasaki GH. Water-assisted liposuction for body contouring and lipoharvesting: safety and efficacy in 41 consecutive patients. Aesthet Surg J. 2011 Jan;31(1):76-88. doi: 10.1177/1090820X10391465.
Ueberreiter K, von Finckenstein JG, Cromme F, Herold C, Tanzella U, Vogt PM. [BEAULI--a new and easy method for large-volume fat grafts]. Handchir Mikrochir Plast Chir. 2010 Dec;42(6):379-85. doi: 10.1055/s-0030-1267913. Epub 2010 Dec 15. German.
Crawford JL, Hubbard BA, Colbert SH, Puckett CL. Fine tuning lipoaspirate viability for fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):1342-1348. doi: 10.1097/PRS.0b013e3181ea44a9.
Herold C, Knobloch K, Grimme M, Vogt PM. Does the injection plane matter in autologous fat transplantation? Aesthetic Plast Surg. 2010 Oct;34(5):678-9. doi: 10.1007/s00266-010-9490-1. No abstract available.
Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
Kanchwala SK, Glatt BS, Conant EF, Bucky LP. Autologous fat grafting to the reconstructed breast: the management of acquired contour deformities. Plast Reconstr Surg. 2009 Aug;124(2):409-418. doi: 10.1097/PRS.0b013e3181aeeadd.
Hamza A, Lohsiriwat V, Rietjens M. Lipofilling in breast cancer surgery. Gland Surg. 2013 Feb;2(1):7-14. doi: 10.3978/j.issn.2227-684X.2013.02.03.
Saint-Cyr M, Rojas K, Colohan S, Brown S. The role of fat grafting in reconstructive and cosmetic breast surgery: a review of the literature. J Reconstr Microsurg. 2012 Feb;28(2):99-110. doi: 10.1055/s-0031-1287675. Epub 2011 Sep 16.
Losken A, Pinell XA, Sikoro K, Yezhelyev MV, Anderson E, Carlson GW. Autologous fat grafting in secondary breast reconstruction. Ann Plast Surg. 2011 May;66(5):518-22. doi: 10.1097/SAP.0b013e3181fe9334.
ELFadl D, Garimella V, Mahapatra TK, McManus PL, Drew PJ. Lipomodelling of the breast: a review. Breast. 2010 Jun;19(3):202-9. doi: 10.1016/j.breast.2010.02.009. Epub 2010 Mar 26.
Costantini M, Cipriani A, Belli P, Bufi E, Fubelli R, Visconti G, Salgarello M, Bonomo L. Radiological findings in mammary autologous fat injections: a multi-technique evaluation. Clin Radiol. 2013 Jan;68(1):27-33. doi: 10.1016/j.crad.2012.05.009. Epub 2012 Jun 30.
Shiffman MA, Mirrafati S. Fat transfer techniques: the effect of harvest and transfer methods on adipocyte viability and review of the literature. Dermatol Surg. 2001 Sep;27(9):819-26. doi: 10.1046/j.1524-4725.2001.01062.x.
Rennekampff HO, Reimers K, Gabka CJ, Germann G, Giunta RE, Knobloch K, Machens HG, Pallua N, Ueberreiter K, Heimburg Dv, Vogt PM. [Current perspective and limitations of autologous fat transplantation--"consensus meeting" of the German Society of Plastic, Reconstructive and Aesthetic Surgeons at Hannover; September 2009]. Handchir Mikrochir Plast Chir. 2010 Apr;42(2):137-42. doi: 10.1055/s-0030-1249672. Epub 2010 Mar 29. German.
Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. doi: 10.1097/01.prs.0000181509.67319.cf.
Smith P, Adams WP Jr, Lipschitz AH, Chau B, Sorokin E, Rohrich RJ, Brown SA. Autologous human fat grafting: effect of harvesting and preparation techniques on adipocyte graft survival. Plast Reconstr Surg. 2006 May;117(6):1836-44. doi: 10.1097/01.prs.0000218825.77014.78.
Schultz I, Lindegren A, Wickman M. Improved shape and consistency after lipofilling of the breast: patients' evaluation of the outcome. J Plast Surg Hand Surg. 2012 Apr;46(2):85-90. doi: 10.3109/2000656X.2011.653256.
Conde-Green A, de Amorim NF, Pitanguy I. Influence of decantation, washing and centrifugation on adipocyte and mesenchymal stem cell content of aspirated adipose tissue: a comparative study. J Plast Reconstr Aesthet Surg. 2010 Aug;63(8):1375-81. doi: 10.1016/j.bjps.2009.07.018. Epub 2009 Aug 12.
Hsu VM, Stransky CA, Bucky LP, Percec I. Fat grafting's past, present, and future: why adipose tissue is emerging as a critical link to the advancement of regenerative medicine. Aesthet Surg J. 2012 Sep;32(7):892-9. doi: 10.1177/1090820X12455658.
Mestak O, Hromadkova V, Fajfrova M, Molitor M, Mestak J. Evaluation of Oncological Safety of Fat Grafting After Breast-Conserving Therapy: A Prospective Study. Ann Surg Oncol. 2016 Mar;23(3):776-81. doi: 10.1245/s10434-015-4908-2. Epub 2015 Oct 14.
Uda H, Sugawara Y, Sarukawa S, Sunaga A. Brava and autologous fat grafting for breast reconstruction after cancer surgery. Plast Reconstr Surg. 2014 Feb;133(2):203-213. doi: 10.1097/01.prs.0000437256.78327.12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RP046D-15HTM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.