Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT03502512
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT03502512
Study Brief:
Protocol Section:
NCT03502512