Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Breast Reconstruction Following Mastectomy

Treatments: Procedure: Prepectoral approach; Procedure: Partial Subpectoral approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04874402

CASE1121

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction

Exclusion criteria

• Active use of any tobacco products
• Uncontrolled diabetes defined by HbA1c greater than 7.5%
• Class II obesity or higher defined by a body mass index equal or greater than 35 kg/m2
• History of radiation to the affect breast or chest
• Immunocompromised patients
• Clinical evidence of significant mastectomy flap ischemia prior to the initiation of the reconstructive procedure

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Prepectoral approach

Active Comparator group

Description:

Immediately following mastectomy, participants will undergo prepectoral reconstruction approach. Intraoperative filling volume will be decided by the attending surgeon based on the pocket dimension and volume capabilities. Participants will be evaluated at 6 time points during the study.

Treatment:

Procedure: Prepectoral approach

Partial subpectoral approach

Experimental group

Description:

Immediately following mastectomy, participants will undergo partial subpectoral reconstruction approach. Intraoperative filling volume will be decided by the attending surgeon based on the pocket dimension and volume capabilities. Participants will be evaluated at 6 time points during the study.

Treatment:

Procedure: Partial Subpectoral approach