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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

EVEBRA device

Intervention Type DEVICE

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

AFT without EVEBRA device (control arm)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EVEBRA device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

23 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No