- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04273464
Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Telemark
-
Skien, Telemark, Norway, 3700
- Telemark Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 -
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brava-group
External 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.
|
Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.
|
Active Comparator: DIEP-group
26 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 %
|
Microsurgical reconstruction by DIEPO method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group
|
Early complications
Time Frame: Three months after first two fat grafting sessions in Brava reonstruction group
|
Complications registered in relation to the surgical sessions
|
Three months after first two fat grafting sessions in Brava reonstruction group
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Telemark breast score
Time Frame: 3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group
|
Using the Telemark braest score for assessment of esthetic result
|
3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hege Kersten, PhD, Sykehuset Telemark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1097.13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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