Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273464
• Other study ID #: 1097.13
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2022

Study information

• Verified date: December 2022
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2022
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women who have consented to participate in the study and underwent mastectomy and radiation therapy.

2. Mammography of the remaining breast performed within 3 months before surgery

3. At least 1 year after completion of radiotherapy

4. BMI between 22 and 32 -

Exclusion Criteria:

1. Patients with recurrent or metastatic breast cancer

2. Patients with pacemakers or metal clips after any surgery

3. Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes

4. Patients with claustrophobia

5. Patients with severe drug abuse

6. Patients with silicone allergy

7. Patients with bleeding disorders

8. Patients who smoke or have smoked in the last two months

Related Conditions & MeSH terms

• Breast Cancer
• Mammaplasty

Intervention

Procedure:
• Brava-group
Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.
• DIEP-group
Microsurgical reconstruction by DIEPO method

Locations

Country	Name	City	State
Norway	Telemark Hospital	Skien	Telemark

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Telemark

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group
Primary	Early complications	Complications registered in relation to the surgical sessions	Three months after first two fat grafting sessions in Brava reonstruction group
Secondary	Telemark breast score	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