Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prepectoral reconstruction

Prepectoral breast reconstruction with Braxon dermal matrix

Group Type EXPERIMENTAL

Prepectoral reconstruction

Intervention Type PROCEDURE

Prepectoral breast reconstruction

Submuscular reconstruction

Submuscolar breast reconstruction

Group Type ACTIVE_COMPARATOR

Submuscolar reconstruction

Intervention Type PROCEDURE

Submuscolar breast reconstruction

Interventions

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Prepectoral reconstruction

Prepectoral breast reconstruction

Intervention Type PROCEDURE

Submuscolar reconstruction

Submuscolar breast reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No