NCT01979757

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

October 28, 2013

Last Update Submit

November 7, 2013

Conditions

Fatgrafting to a Breast After Breast Conserving Therapy

Outcome Measures

Primary Outcomes (1)

  • Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy

    1 year

Study Arms (2)

Centrifugation

ACTIVE COMPARATOR

Patients recieved fatgraft processed by Centrifugation

Other: Centrifugation

Puregraft

ACTIVE COMPARATOR

Patients recieved fatgraft processed by Puregraft

Other: Puregraft

Interventions

PuregraftOTHER
Puregraft
CentrifugationOTHER
Centrifugation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • State after breast conserving therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulovka Hospital

Prague, 180 00, Czechia

Location

MeSH Terms

Interventions

Centrifugation

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ondrej Mestak, M.D.

    Charles University, Czech Republic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 8, 2013

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

CZ(1)