Clinical trial · Observational
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.
- 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)
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes. The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session. For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients. The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization). The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.
Conditions
Conditions (1)
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 Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast reconstruction
- description
- Women who have had a mastectomy and want a secondary breast reconstruction by implant.
- interventionNames
- Procedure: Breast reconstruction
Primary outcomes (1)
- measure
- Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
- timeFrame
- 12 months
- description
- Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)
Secondary outcomes (2)
- measure
- Evaluate the aesthetic result
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman aged over 18 * Medical history of mastectomy +/- radiotherapy * Woman requesting breast reconstruction by implant * Patient treated for non-metastatic cancer Exclusion Criteria: * Locally uncontrolled disease * Metastatic disease * Patient with major cutaneous atrophy allowing only flap reconstruction * Patients under guardianship or trusteeship * Patients who objected to the research
References
Publications (0)
Data not yet available