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Breast CancerNCT04273464

Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?

A study testing Brava-group and DIEP-group in people with Breast Cancer and Mammaplasty, run by Sykehuset Telemark at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983 become golden standard in autologous… Read more about this study

Who is it for?
Ages 20 to 70 years, women only
Conditions the study is for
Breast Cancer, Mammaplasty
What is being tested?
Brava-group and DIEP-group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteNorway
Study dates
Jun 2016to Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women who have consented to participate in the study and underwent mastectomy and radiation therapy.
  • Mammography of the remaining breast performed within 3 months before surgery
  • At least 1 year after completion of radiotherapy
  • BMI between 22 and 32 -

Who cannot join

  • Patients with recurrent or metastatic breast cancer
  • Patients with pacemakers or metal clips after any surgery
  • Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
  • Patients with claustrophobia
  • Patients with severe drug abuse
  • Patients with silicone allergy
  • Patients with bleeding disorders
  • Patients who smoke or have smoked in the last two months

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Telemark Hospital

    Skien, Telemark, 3700

Other trials in Norway

About this study

Official title: Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation

Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983 become golden standard in autologous breast reconstruction. The deep inferior epigastric perforator (DIEP)-flap, the very last improvement of TRAM flap, has been used in breast reconstruction after mastectomy and radiation therapy as the method of choice at the Department for Plastic Surgery at Hospital of Telemark since 2000.Transplantation of fat tissue by lipoinjections is an alternative method for partial breast reconstruction. In recent years, fat transplantation techniques have gained interest even for patients after mastectomy, as donor site morbidity and operative trauma seem to be less than when free flaps are used. Best results are obtained if the skin around mastectomy scar is pretreated with external expansion. The results of breast reconstruction with fat transplantation are promising, but have not been compared to microsurgical reconstruction of the breast in a scientific manner. The present project is designed to address clinical questions regarding efficiency and patient satisfaction of the two methods.

Read the detailed description

When used for breast reconstruction on irradiated patients, breast implants can result in 50% or higher rate of complications included capsular contracture and implant rupture. For this reasons secondary breast reconstruction in irradiated patients is preferably done with autologous tissue.Reconstruction methods employing microvascular transfer of autologous tissue are time consuming having a long learning curve for surgeons. The present project aims to evaluate fat transplantation in combination with external tissue expansion (Brava method) as an alternative to microsurgical complexe methods.

Hypothesis: Early complication/ drop out occur more frequently in fat transplantated patients.

Methods: External tissue expanders (Brava, Brava, LLC 14221 SW 142nd St, Miami, FL 33186) will be used 3 weeks prior to reconstruction in order to enhance the volume and survival of fat cells. The investigators expect that each patient in the fat transplantation group will need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume and shape of the breast. The investigators expect 1-2 operative sessions of respectively 5-7 and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during the first postoperative week) in the DIEP group is 5-10 %.

Patients in the fat transplantation group experiencing poor compliance or early complications as well as patients with unsatisfactory results will be offered alternative methods of reconstruction such as superior or inferior gluteal perforator flap (SGAP or IGAP), Latissimus dorsi pedicled flap alone or in combination with implant. In some cases even simple implant reconstruction could be offered assuming that the quality of previously irradiated skin has been improved by fat transplants .

Study design: Prospective cohort study

Hypothesis: Reconstruction with BRAVA and fat transplantation is a good alternative to reconstruction with DIEP flap.

Study variables: MRI-based volume estimates, anthropometric measurements, VAS scale (Breast-Q - questionnaire measuring patient-related outcome) and Telemark breast score evaluation through independent investigators

Statistics: Power analysis determine that 25 patients are required in each group in this study considering 80 % power with 95 % significance and 40 % difference with regard to patient satisfaction and early complications.

Follow-up: 6 months after DIEP reconstruction and 3 months after the second session of fat transplantation.

Primary endpoint: assessment of early complications in both study groups

Secondary endpoint: patient satisfaction with shape and symmetry of the breast, Satisfaction with psychosocial, psychological and sexual well-being, satisfaction with process of care, shape of the body and postoperative scars (Breast-Q).

Being tested
Brava-group, DIEP-group
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brava-groupProcedure or surgery

    Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.

  • DIEP-groupProcedure or surgery

    Microsurgical reconstruction by DIEPO method

Study groups in NCT04273464
Study groupRoleWhat they receive
Brava-groupExperimentalExternal tissue expanders will be used 3 weeks prior to operation and 2 weeks postoperatively in order to enhance the volume and survival of fat cells. We expect that each patient in the fat transplantation group will need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume and shape of the breast.31 participants.
Receives: Procedure: Brava-group
DIEP-groupActive comparator26 participants. We expect 1-2 operative sessions of respectively 5-7 and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during the first postoperative week) in the DIEP group is 5-10 %
Receives: Procedure: DIEP-group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast-Q reconstructive module

    Patient-related outcome by Breast-Q questionnaire. The Breast-Q™ was developed and provided by the Memorial Sloan Kettering Cancer Center (New York, USA) and the University of British Columbia (Vancouver, British Columbia, Canada). Translation of the BCT Breast-Q™ module into Norwegian was approved in 2014. The questionnaire contains nine domains: satisfaction with breasts, adverse effects of radiation, psychosocial and physical well-being, and different aspects of satisfaction with care. Breast Q preoperative and Breast QQ Breast Q pre- and postoperative scores were registered

    Measured: Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group

  2. Early complications

    Complications registered in relation to the surgical sessions

    Measured: Three months after first two fat grafting sessions in Brava reonstruction group

Secondary outcomes (1)

  1. Telemark breast score

    Using the Telemark braest score for assessment of esthetic result

    Measured: 3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study startJun 2016
  3. Primary completionAug 2020
  4. Study completionFeb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective comparative study of two parallell cohorts (BRAVA and DIEP reconstruction methods).
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04273464
Sponsor's protocol ID
1097.13
Status last verified
Dec 2022
First submitted
29 Oct 2018
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Begic A, Tolli J, Hegard W, Stark B. Secondary Breast Reconstruction in Irradiated Patients: Prospective Trial Comparing DIEP to Brava Expansion and Fat Transplantation. Plast Reconstr Surg. 2023 Aug 1;152(2):205e-216e. doi: 10.1097/PRS.0000000000010250. Epub 2023 Feb 1.

    PubMed 36723980

Questions about this trial

What is this clinical trial studying?

A study testing Brava-group and DIEP-group in people with Breast Cancer and Mammaplasty, run by Sykehuset Telemark at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast-Q reconstructive module (time frame: Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04273464, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.

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