Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast

Bulovka Hospital

Status: Completed

Conditions: Fatgrafting to a Breast After Breast Conserving Therapy

Treatments: Other: Puregraft; Other: Centrifugation

Study type: Interventional

Funder types: Other

Identifiers

NCT01979757

CentPure

268011 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• State after breast conserving therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Centrifugation

Active Comparator group

Description:

Patients recieved fatgraft processed by Centrifugation

Treatment:

Other: Centrifugation

Puregraft

Active Comparator group

Description:

Patients recieved fatgraft processed by Puregraft

Treatment:

Other: Puregraft