Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

European Institute of Oncology

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Submuscolar reconstruction; Procedure: Prepectoral reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05125991

IEO 1002/

Details and patient eligibility

About

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.

Full description

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.

The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.

Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.

Enrollment: 58 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Prepectoral reconstruction

Experimental group

Description:

Prepectoral breast reconstruction with Braxon dermal matrix

Treatment:

Procedure: Prepectoral reconstruction

Submuscular reconstruction

Active Comparator group

Description:

Submuscolar breast reconstruction

Treatment:

Procedure: Submuscolar reconstruction