Clinical trial · Interventional
Evaluation of the Effectiveness of Prepectoral Breast Reconstruction
Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study
NCT05125991CI-TRIAL-00069070unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prepectoral reconstruction | Procedure | — | UNRESOLVED |
| Submuscolar reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prepectoral reconstruction
- description
- Prepectoral breast reconstruction with Braxon dermal matrix
- interventionNames
- Procedure: Prepectoral reconstruction
- type
- ACTIVE_COMPARATOR
- label
- Submuscular reconstruction
- description
- Submuscolar breast reconstruction
- interventionNames
- Procedure: Submuscolar reconstruction
Primary outcomes (1)
- measure
- Satisfaction assessed by the BREAST-Q
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent 2. Not smokers 3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders) 4. BMI\<30 5. CUP B-C (or mastectomy estimated weight less than 550gm) 6. Good subcutaneous layer (\>1cm on pinch test measured in upper/medial quadrant) 7. No previous breast surgery 8. No previous breast irradiation 9. Breast Ptosis 1-2 according to Renault's classification 10. DCIS tumors 11. T1 T2 pN0 breast tumor with known favourable biologic features Exclusion Criteria: 1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality) 2. Positive sentinel node biopsy requiring complete axillary dissection
References
Publications (0)
Data not yet available
No reference posted for this study.