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OpenTrials
Completed

NCT Number: NCT01979757

Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bulovka Hospital

Prague, 180 00, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • State after breast conserving therapy

Treatment and study plan

Puregraft

Other

Centrifugation

Other

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bulovka Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2013
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.