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
| Type | Name | Description |
|---|---|---|
| OTHER | Puregraft | |
| OTHER | Centrifugation |
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.