Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast

Fatgrafting to a Breast After Breast Conserving Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979757
• Other study ID #: CentPure
• Secondary ID: 268011
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: November 7, 2013
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Bulovka Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• State after breast conserving therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatgrafting to a Breast After Breast Conserving Therapy

Intervention

Other:
• Puregraft

• Centrifugation

Locations

Country	Name	City	State
Czech Republic	Bulovka Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Bulovka Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy		1 year	No