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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Reconstruction Following Mastectomy

Intervention / Treatment
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* Procedure: Prepectoral approach
* Procedure: Partial Subpectoral approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prepectoral approach<br>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<br>* 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<br>|
| Experimental: Partial subpectoral approach<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |