External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

NCT05003635 | Recruiting DMC

• 1 other identifier: METC20-099
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

fat grafting; lipoaspirate; fat injection; fat transfer; lipofilling; liposculpturing; lipoinjection; lipotransfer; breast reconstruction; external pre-expansion; BRAVA; EVE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The quality of the reconstructed breast tissue as determined by MRI.

  12 months

• The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire

  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.

  12 months

• Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line

  12 months

Study Arms (2)

AFT+ EVEBRA device (intervention arm)

ACTIVE COMPARATOR

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

AFT without EVEBRA device (control arm)

NO INTERVENTION

Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device.

Interventions

EVEBRA device DEVICE

Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.

AFT+ EVEBRA device (intervention arm)

Eligibility Criteria

• Age: 23 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (3)

Maastricht University Medical Center+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Amsterdam University Medical Center (VUMC)

Amsterdam, Netherlands

RECRUITING

Ziekenhuis groep Twente (ZGT)

Hengelo, Netherlands

RECRUITING

Study Officials

• Andrzej Piatkowski de Gryzmala, MD, MsC

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maud Rijkx, MD, MsC

CONTACT

+31 (0) 43 38 723 08; maud.rijkx@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 12, 2021
• Study Start: July 12, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 3, 2022

Record last verified: 2021-08

Locations

NL (3)