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Clinical Trial Summary

The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.


Clinical Trial Description

This is a single center, single-blinded, randomized clinical trial involving adult women undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction. The aim is to generate high quality evidence before establishing the prepectoral technique as routine care. A favorable safety and patient satisfaction profile will bring high quality evidence supporting the adoption of a technique that has shown similar complication rates while eliminating animation deformity and its associated pain and discomfort in retrospective and non-randomized studies. The mastectomy flap perfusion will be assessed clinically and using SPY fluorescence imaging. Immediately following mastectomy, participants will be randomized to one of two treatment arms. Group A will be composed of participants who will undergo prepectoral reconstruction with Acellular Dermal Matrix (ADM) by means of the anterior tenting technique. In this technique, two sheets of contour, fenestrated ADM sutured together are trimmed in accordance with the measurement of the expander/implant and fixed to the pectoralis major muscle covering the entire anterior surface of the device Group B (current standard of care (SOC)) will be composed of participants who will undergo partial subpectoral reconstruction with ADM by means of the sling technique. In this technique the leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned. The lower medial origin muscle fibers are released for anatomical expander seating. An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold (over the expander) and laterally to close the expander pocket. ;


Study Design


Related Conditions & MeSH terms

  • Breast Reconstruction Following Mastectomy

NCT number NCT04874402
Study type Interventional
Source Case Comprehensive Cancer Center
Contact
Status Withdrawn
Phase N/A
Start date October 1, 2023
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Recruiting NCT05031962 - Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
Completed NCT02775409 - Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction N/A