Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?

NCT ID: NCT04273464

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-02-28

Brief 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.

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).

Conditions

Breast Cancer; Mammaplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brava-group

Intervention Type: PROCEDURE

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

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 %

Group Type: ACTIVE_COMPARATOR

DIEP-group

Intervention Type: PROCEDURE

Microsurgical reconstruction by DIEPO method

Interventions

Brava-group

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

Intervention Type: PROCEDURE

DIEP-group

Microsurgical reconstruction by DIEPO method

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Telemark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hege Kersten, PhD

Role: STUDY_DIRECTOR

Sykehuset Telemark

Locations

Telemark Hospital

Skien, Telemark, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 36723980 (View on PubMed)

Other Identifiers

1097.13

Identifier Type: -

Identifier Source: org_study_id