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

Breast Reconstruction Following Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04874402
• Other study ID #: CASE1121
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction Following Mastectomy

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida, Case Comprehensive Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Preoperatively
Secondary	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 1
Secondary	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 7 +/-7 days
Secondary	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 14 +/-7 days
Secondary	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	postoperative day 21 +/-7 days
Secondary	Overall complication rates	Overall complication rates in both arms. Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	postoperative day 90 +/-30 days
Secondary	Specific complication rates	Presence of seroma, hematoma, superficial and deep surgical site infection, wound dehiscence, skin necrosis, capsular contracture, rippling/visibility/palpability, and implant loss. Furthermore, the complications will be classified in major or minor based on the need for a surgical intervention to treat the complication or not, respectively.; Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Preoperatively
Secondary	Specific complication rates	Presence of seroma, hematoma, superficial and deep surgical site infection, wound dehiscence, skin necrosis, capsular contracture, rippling/visibility/palpability, and implant loss. Furthermore, the complications will be classified in major or minor based on the need for a surgical intervention to treat the complication or not, respectively.; Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 1
Secondary	Specific complication rates	Presence of seroma, hematoma, superficial and deep surgical site infection, wound dehiscence, skin necrosis, capsular contracture, rippling/visibility/palpability, and implant loss. Furthermore, the complications will be classified in major or minor based on the need for a surgical intervention to treat the complication or not, respectively.; Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 7 +/-7 days
Secondary	Specific complication rates	Presence of seroma, hematoma, superficial and deep surgical site infection, wound dehiscence, skin necrosis, capsular contracture, rippling/visibility/palpability, and implant loss. Furthermore, the complications will be classified in major or minor based on the need for a surgical intervention to treat the complication or not, respectively.; Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	Postoperative day 14 +/-7 days
Secondary	Specific complication rates	Presence of seroma, hematoma, superficial and deep surgical site infection, wound dehiscence, skin necrosis, capsular contracture, rippling/visibility/palpability, and implant loss. Furthermore, the complications will be classified in major or minor based on the need for a surgical intervention to treat the complication or not, respectively.; Fisher's exact test will be performed to evaluate the differences in overall and specific complication rates between the two arms	postoperative day 21 +/-7 days
Secondary	Postoperative pain intensity	Pain intensity evaluated using a visual analog scale. A mixed model with repeated measures will be conducted to analyze the differences in the postoperative pain at the immediate postoperative period and during the tissue expansion phase between the two arms	Postoperative day 1
Secondary	Postoperative pain intensity	Pain intensity evaluated using a visual analog scale. A mixed model with repeated measures will be conducted to analyze the differences in the postoperative pain at the immediate postoperative period and during the tissue expansion phase between the two arms	Postoperative day 7 +/-7 days
Secondary	Postoperative pain intensity	Pain intensity evaluated using a visual analog scale. A mixed model with repeated measures will be conducted to analyze the differences in the postoperative pain at the immediate postoperative period and during the tissue expansion phase between the two arms	Postoperative day 14 +/-7 days
Secondary	Postoperative pain intensity	Pain intensity evaluated using a visual analog scale. A mixed model with repeated measures will be conducted to analyze the differences in the postoperative pain at the immediate postoperative period and during the tissue expansion phase between the two arms	postoperative day 21 +/-7 days