- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979757
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Prague, Czech Republic, 180 00
- Bulovka Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- State after breast conserving therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Centrifugation
Patients recieved fatgraft processed by Centrifugation
|
|
Active Comparator: Puregraft
Patients recieved fatgraft processed by Puregraft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ondrej Mestak, M.D., Charles University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CentPure
- 268011 (Other Grant/Funding Number: Grant Agency of Charles University in Prague)
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