Cosmetic TechniquesLipofillingNCT03016663

Volumetric Study of Fat Resorption After Breast Lipofilling

An observational study of Cosmetic Techniques and Mammaplasty, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cosmetic Techniques, Mammaplasty
What is being tested?: Technique of Breast Lipofilling
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 10 participants
Where: 1 siteMalaysia
Study dates: Sep 2015to Dec 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Patient with past history of breast cancer recruited.

Who may be able to join

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.

Who cannot join

Patients are excluded if they experienced local recurrence or distant metastasis

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

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

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

Conditions: Cosmetic Techniques, Mammaplasty
Being tested: Technique of Breast Lipofilling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Technique of Breast LipofillingProcedure or surgery
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.

Study groups in NCT03016663
Study group	Role	What they receive
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 Receives: Procedure: Technique of Breast Lipofilling

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 6 month after breast lipofilling

Secondary outcomes (1)

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
Measured: 6 month after breast lipofilling

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2016

First posted10 Jan 2017 (estimated)
Study startSep 2015
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Cosmetic TechniquesStudies of the same condition, open and under way.
More trials run by University of MalayaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03016663
Sponsor's protocol ID: RP046D-15HTM
Acronym: Lipofilling
Status last verified: Jan 2017
First submitted: 9 Jan 2017
Last updated: 10 Jan 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 24076696
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.
PubMed 24154518
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.
PubMed 21502905
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.
PubMed 22488516
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.
PubMed 21239675
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.
PubMed 21161858
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.
PubMed 20885257
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.
PubMed 20333518
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.
PubMed 16936550
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.
PubMed 19644255
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.
PubMed 25083450
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.
PubMed 21928171
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.
PubMed 21451387
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.
PubMed 20347309
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.
PubMed 22749812

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIPOFILLING IN BREAST SURGERY: VOLUMETRIC EVALUATION OF FAT RESORPTION AFTER WASHING WITH RINGER'S LACTATE
ClinicalTrials.gov ID: NCT03016663
Acronym / sponsor ID: Lipofilling / RP046D-15HTM
Conditions: Cosmetic Techniques, Mammaplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of MalayaUniversity, hospital or other
Study start: Sep 2015
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 10 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Breast Lipofilling Technique	–	Procedure: Technique of Breast LipofillingPreliminary 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient with past history of breast cancer recruited.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Patients are excluded if they experienced local recurrence or distant metastasis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Technique of Breast Lipofilling1. 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.	Procedure or surgery	Breast Lipofilling Technique

Primary outcome

Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging
Time frame: 6 month after breast lipofilling
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)

1 secondary outcome

Confounding factors
Time frame: 6 month after breast lipofilling

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
Background: PubMed 24076696Fiaschetti 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.
Background: PubMed 24154518Agha 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.
Background: PubMed 21502905Petit 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.
Background: PubMed 22488516Claro 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.
Background: PubMed 21239675Sasaki 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.
Background: PubMed 21161858Ueberreiter 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.
Background: PubMed 20885257Crawford 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.
Background: PubMed 20333518Herold 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.
Background: PubMed 16936550Coleman 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.
Background: PubMed 19644255Kanchwala 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.
Background: PubMed 25083450Hamza 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.
Background: PubMed 21928171Saint-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alizan ABDUL KHALIL principal investigator

Department of Surgery University Malaya Medical Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cosmetic Techniques and Mammaplasty, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging (time frame: 6 month after breast lipofilling). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016663, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.