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Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast

Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01979757
Enrollment
30
Registered
2013-11-08
Start date
2011-04-30
Completion date
2013-09-30
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatgrafting to a Breast After Breast Conserving Therapy

Brief summary

Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity. Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics, USA) is a new method that involves washing and filtering the fat to prepare the graft. The investigators compared the subjective and objective outcomes of two fat-processing methods, centrifugation and PureGraft filtration. Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT in our department between April 2011 and September 2012. The patients were preoperatively divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15 received fatgrafts processed by washing in PureGraft bags. The patients were followed up for 12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q questionnaire to all the patients both preoperatively and one year postoperatively. The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.

Interventions

OTHERPuregraft

Sponsors

Bulovka Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* State after breast conserving therapy

Design outcomes

Primary

MeasureTime frame
Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy1 year

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026