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

NCT04874402 | Withdrawn

• 1 other identifier: CASE1121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction Following Mastectomy

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction as measured by BREAST-Q-scores

  Patient satisfaction will be assessed using BREAST-Q-scores. BREAST-Q is a patient-reported outcome instrument used to assess the outcomes of different breast surgeries among women. Modules selected will be "Psychosocial Well-Being, Physical Well-Being: Chest and Satisfaction with Breasts" within the Reconstruction (Preoperative) module and "Psychosocial Well-Being, Physical Well-Being: Chest, Satisfaction with Breasts and Satisfaction with Implants" within the Reconstruction (Postoperative) module For each BRESAT-Q scale, items are summed and transformed to a score with range from 0 to 100, and with greater values representing more satisfaction and higher levels of breast related quality of life. A two-sample T-test will be used to assess the changes in mean scores of satisfaction between two arms

  Preoperatively

• Patient satisfaction as measured by BREAST-Q-scores

  Patient satisfaction will be assessed using BREAST-Q-scores. BREAST-Q is a patient-reported outcome instrument used to assess the outcomes of different breast surgeries among women. Modules selected will be "Psychosocial Well-Being, Physical Well-Being: Chest and Satisfaction with Breasts" within the Reconstruction (Preoperative) module and "Psychosocial Well-Being, Physical Well-Being: Chest, Satisfaction with Breasts and Satisfaction with Implants" within the Reconstruction (Postoperative) module For each BRESAT-Q scale, items are summed and transformed to a score with range from 0 to 100, and with greater values representing more satisfaction and higher levels of breast related quality of life. A two-sample T-test will be used to assess the changes in mean scores of satisfaction between two arms

  postoperative day 90 +/-30 days

Secondary Outcomes (15)

• Overall complication rates

  Preoperatively

• Overall complication rates

  Postoperative day 1

• Overall complication rates

  Postoperative day 7 +/-7 days

• Overall complication rates

  Postoperative day 14 +/-7 days

• Overall complication rates

  postoperative day 21 +/-7 days

Study Arms (2)

Prepectoral approach

ACTIVE COMPARATOR

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.

Procedure: Prepectoral approach

Partial subpectoral approach

EXPERIMENTAL

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.

Procedure: Partial Subpectoral approach

Interventions

Prepectoral approach 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

Prepectoral approach

Partial Subpectoral approach 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.

Partial subpectoral approach

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Florida, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

Location

Study Officials

• Amir Ghaznavi, MD

  Cleveland Clinic Florida, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)