Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05125991
• Other study ID #: IEO 1002/
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Prepectoral reconstruction
Prepectoral breast reconstruction
• Submuscolar reconstruction
Submuscolar breast reconstruction

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction assessed by the BREAST-Q	The BREAST-Q survey is used to detect differences in patient satisfaction among the groups	1 year
Secondary	Immediate complications rate	Compare post operative complications	1 month
Secondary	Short term complications rate	Compare short term post operative complications	6 months
Secondary	Long term complications rate	Compare long term post operative complications	24 months
Secondary	Percentage of capsular contracture	Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers	1 year