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

NCT ID: NCT04874402

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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.

Conditions

Breast Reconstruction Following Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Prepectoral approach

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.

Group Type: ACTIVE_COMPARATOR

Prepectoral approach

Intervention Type: PROCEDURE

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 (superiorly, medially, and inferiorly) and serratus fascia (laterally), covering the entire anterior surface of the device

Partial subpectoral approach

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.

Group Type: EXPERIMENTAL

Partial Subpectoral approach

Intervention Type: PROCEDURE

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. In both groups, the size of the expander and the intraoperative filling volume will be decided by the attending surgeon based on the pocket dimension and volume capabilities.

Interventions

Prepectoral approach

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 (superiorly, medially, and inferiorly) and serratus fascia (laterally), covering the entire anterior surface of the device

Intervention Type: PROCEDURE

Partial Subpectoral approach

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. In both groups, the size of the expander and the intraoperative filling volume will be decided by the attending surgeon based on the pocket dimension and volume capabilities.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir Ghaznavi, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Florida, Case Comprehensive Cancer Center

Weston, Florida, United States

Countries

United States

Other Identifiers

CASE1121

Identifier Type: -

Identifier Source: org_study_id