NCT05125991

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Prepectoral reconstruction	Prepectoral breast reconstruction
PROCEDURE	Submuscolar reconstruction	Submuscolar breast reconstruction

Timeline

• Start date: 2019-09-03
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2021-11-18
• Last updated: 2023-08-24

Locations

1 site across 1 country: Italy