External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery (EVE)

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: EVEBRA device

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maud Rijkx, MD, MsC; Phone Number: +31 (0) 43 38 723 08; Email: maud.rijkx@mumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Center (VUMC)
    • Contact: Jan Maerten Smit, MD, MsC
  • Hengelo, Netherlands
    • Recruiting
    • Ziekenhuis Groep Twente (ZGT)
    • Contact: Ute Schmidbauer, MD, PhD
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht University Medical Center+
      • Contact: Andrzej Piatkowski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Age 23-69
• BMI 18-35 - stable weight, no fluctuations
• Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
• Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
• Assessed by surgeon to have enough donor fat
• Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)

Exclusion Criteria:

• untreated breast cancer
• history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure
• completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)
• except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
• had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
• mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall
• has a pacemaker or aneurysm clips
• pregnancy or breastfeeding
• had a cardiac stent placed within the last 2 months
• claustrophobic, as reported by patient
• known current substance abuse, as reported by patient
• history of silicone allergy, as reported by patient
• history of Gadolinium allergy, as reported by patient
• history of lidocaine allergy, as reported by patient
• bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
• medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AFT+ EVEBRA device (intervention arm); Before and after the AFT surgery, patients are required to wear the EVEBRA expansion device for a total duration of 4 weeks. Thereafter patients will receive a PexyBra over the reconstructed breast. Pre-operatively patients are required to wear the device for a total of 200 hours.	Device: EVEBRA device; Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.
No Intervention: AFT without EVEBRA device (control arm); Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness measured in volume (MRI)	All women will have an MRI for Baseline Breast Volume measurement at the time of enrollment. Final breast volume will be also determined by MRI 6 months after the first grafting procedure (AFT#1). The primary effectiveness endpoint is the Percentage Augmentation of the mastectomy defect at 12 months after AFT#1.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of the reconstructed breast tissue as determined by MRI.	Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters)	12 months
The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire	Qscore will be used to assess final scores. As described in the BREAST-Q Module, summed scores will be converted into a score from 0 (worst) to 100 (best) per domain. Higher scores reflect a better outcome.	12 months
Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels)		12 months
Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5.	The aesthetic improvement will be rated using pre-operative and one year post-operative 2D images by a group of experts, breast cancer patients and age-matched male and female laymen. All parties rate the pre-/post- 3D images on a Likert scale (5 points) with one indicating no improvement and 5 indicating perfect improvement.	12 months
Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line	Difference noted in centimeters (cm)	12 months
Difference in bra cup size	Cup size before and after reconstruction will be noted .	12 months
Difference in Breast Volume from the randomization baseline after the three sessions of fat grafting (Final Reconstructed Breast Volumes) as measured by the validated Vectra 3D imaging system and the MRI.	Volume change will be noted in cubic centimetre(cc)	12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Andrzej Piatkowski de Gryzmala, MD, MsC, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breast reconstruction; fat grafting; fat injection; lipoaspirate; fat transfer; lipofilling; liposculpturing; lipoinjection; lipotransfer; external pre-expansion; BRAVA; EVE
• Other Study ID Numbers: METC20-099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No