Clinical trial · Interventional
Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mammaplasty | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brava-group | Procedure | — | UNRESOLVED |
| DIEP-group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brava-group
- description
- 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.
- interventionNames
- Procedure: Brava-group
- type
- ACTIVE_COMPARATOR
- label
- DIEP-group
- description
- 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 %
- interventionNames
- Procedure: DIEP-group
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBegic 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. PMID 36723980