REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2021-08-06

Brief Summary

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This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.

SECONDARY OBJECTIVES:

I. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.

II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.

III. To measure patient reported outcomes (PRO, BREAST-Questionnaire \[Q\], Body Image Survey).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo reconstructive surgery with REVOLVE technique.

ARM II: Patients undergo reconstructive surgery with PureGraft technique.

After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.

Conditions

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Mammoplasty Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (REVOLVE technique)

Patients undergo reconstructive surgery with REVOLVE technique.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Reconstructive Surgery

Intervention Type PROCEDURE

Undergo reconstructive surgery with REVOLVE technique

Arm II (PureGraft technique)

Patients undergo reconstructive surgery with PureGraft technique.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Reconstructive Surgery

Intervention Type PROCEDURE

Undergo reconstructive surgery with PureGraft technique

Interventions

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Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Reconstructive Surgery

Undergo reconstructive surgery with REVOLVE technique

Intervention Type PROCEDURE

Reconstructive Surgery

Undergo reconstructive surgery with PureGraft technique

Intervention Type PROCEDURE

Other Intervention Names

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Reconstruction Reconstruction

Eligibility Criteria

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Inclusion Criteria

* Previous breast surgery, either mastectomy or partial mastectomy
* Patients with available harvest sites for fat grafting
* Patients with body mass index (BMI) \> 20
* Anticipated harvested fat volume \> 100 cc
* Patients are willing and able to give consent

Exclusion Criteria

* Patients with active cancer, including primary cancer, recurrent cancer and locally or distantly metastatic cancer
* Patients who are unable to provide consent
* Patients who are suspected or known to be pregnant

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes