Volumetric Study of Fat Resorption After Breast Lipofilling

Mammaplasty Clinical Trial

— Lipofilling  

Official title:

LIPOFILLING IN BREAST SURGERY: VOLUMETRIC EVALUATION OF FAT RESORPTION AFTER WASHING WITH RINGER'S LACTATE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016663
• Other study ID #: RP046D-15HTM
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 9, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Prospective observational study to evaluate effects on washing to improve viability of fat grafts in breast lipofilling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with breast defect post breast surgery and unsatisfied. The first lipofilling procedure delayed for at least 9 months after the completion of radiotherapy. Patient on chemotherapy deferred until at least 6 month of last chemotherapy.

Exclusion Criteria:

• Patients are excluded if they experienced local recurrence or distant metastasis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cosmetic Techniques
• Mammaplasty

Intervention

Procedure:
• Technique of Breast Lipofilling
Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker. 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). 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. Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn.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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Lembah Pantai	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (24)

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. — View Citation

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. Review. — View Citation

Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. — View Citation

Condé-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. — View Citation

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. — View Citation

Crawford JL, Hubbard BA, Colbert SH, Puckett CL. Fine tuning lipoaspirate viability for fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):1342-8. doi: 10.1097/PRS.0b013e3181ea44a9. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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):409-18. doi: 10.1097/PRS.0b013e3181aeeadd. Review. — View Citation

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. — View Citation

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. — View Citation

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):341-6. doi: 10.1097/PRS.0b013e31821e713c. Erratum in: Plast Reconstr Surg. 2011 Dec;128(6):1317. — View Citation

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. German. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):203-13. doi: 10.1097/01.prs.0000437256.78327.12. — View Citation

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. German. Erratum in: Handchir Mikrochir Plast Chir. 2011 Feb;43(1):65. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging	MRI Breast performed before the first lipofilling session, at 1st and 6th months after the lipofilling procedure. Volume measurement performed using OsiriX (v7.0.3, 64 bit , Pixmeo c)	6 month after breast lipofilling	No
Secondary	Confounding factors	To identify confounding factors that affect fat resorption rate in breast lipofilling To evaluate the fat resorption following breast lipofilling with volumetric MRI imaging	6 month after breast lipofilling	No