Clinical Trials Directory

Trials / Completed

CompletedNCT01979757

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
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Bulovka Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPuregraft
OTHERCentrifugation

Timeline

Start date
2011-04-01
Primary completion
2013-08-01
Completion
2013-09-01
First posted
2013-11-08
Last updated
2013-11-08

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT01979757. Inclusion in this directory is not an endorsement.