- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874402
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amir Ghaznavi, MD
- Phone Number: 954-659-5220
- Email: ghaznaa@ccf.org
Study Locations
-
-
Florida
-
Weston, Florida, United States, 33331
- Cleveland Clinic Florida, Case Comprehensive Cancer Center
-
Contact:
- Amir Ghaznavi, MD
- Phone Number: 954-659-5220
- Email: ghaznaa@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction as measured by BREAST-Q-scores
Time Frame: Preoperatively
|
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
Time Frame: postoperative day 90 +/-30 days
|
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
Time Frame: Preoperatively
|
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
Time Frame: Postoperative day 1
|
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
Time Frame: Postoperative day 7 +/-7 days
|
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
Time Frame: Postoperative day 14 +/-7 days
|
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
Time Frame: postoperative day 21 +/-7 days
|
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
Time Frame: postoperative day 90 +/-30 days
|
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
Time Frame: Preoperatively
|
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
Time Frame: Postoperative day 1
|
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
Time Frame: Postoperative day 7 +/-7 days
|
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
Time Frame: Postoperative day 14 +/-7 days
|
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
Time Frame: postoperative day 21 +/-7 days
|
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
Time Frame: Postoperative day 1
|
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
Time Frame: Postoperative day 7 +/-7 days
|
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
Time Frame: Postoperative day 14 +/-7 days
|
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
Time Frame: postoperative day 21 +/-7 days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Ghaznavi, MD, Cleveland Clinic Florida, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CASE1121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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