Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03502512
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase N/A
Start date February 13, 2018
Completion date August 6, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04003038 - Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery N/A
Withdrawn NCT04063410 - Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy N/A