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

June 15, 2023 updated by: Case Comprehensive Cancer Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Amir Ghaznavi, MD
  • Phone Number: 954-659-5220
  • Email: ghaznaa@ccf.org

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amir Ghaznavi, MD, Cleveland Clinic Florida, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE1121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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