Breast Reconstruction Following MastectomyNCT04874402
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
A study testing Prepectoral approach and Partial Subpectoral approach in people with Breast Reconstruction Following Mastectomy, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Reconstruction Following Mastectomy
- What is being tested?
- Prepectoral approach and Partial Subpectoral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Florida, Case Comprehensive Cancer Center
Weston, Florida, 33331
About this study
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.
Read the 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.
- Being tested
- Prepectoral approach, Partial Subpectoral approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepectoral approachProcedure or surgery
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 approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Partial Subpectoral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: postoperative day 90 +/-30 days
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: postoperative day 21 +/-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction Following MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Ghaznavi, MD, Principal investigator, Cleveland Clinic Florida, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874402
- Sponsor's protocol ID
- CASE1121
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04874402
- Acronym / sponsor ID
- CASE1121
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepectoral approach | Active comparator | Procedure: Prepectoral approachImmediately 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. |
| Partial subpectoral approach | Experimental | Procedure: Partial Subpectoral approachImmediately 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepectoral approachTwo 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 | Procedure or surgery | Prepectoral approach |
| Partial Subpectoral approachThe 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. | Procedure or surgery | Partial subpectoral approach |
Primary outcome
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
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
15 secondary outcomes
Overall complication rates
Time frame: Preoperatively
Overall complication rates
Time frame: Postoperative day 1
Overall complication rates
Time frame: Postoperative day 7 +/-7 days
Overall complication rates
Time frame: Postoperative day 14 +/-7 days
Overall complication rates
Time frame: postoperative day 21 +/-7 days
Overall complication rates
Time frame: postoperative day 90 +/-30 days
Specific complication rates
Time frame: Preoperatively
Specific complication rates
Time frame: Postoperative day 1
Specific complication rates
Time frame: Postoperative day 7 +/-7 days
Specific complication rates
Time frame: Postoperative day 14 +/-7 days
Specific complication rates
Time frame: postoperative day 21 +/-7 days
Postoperative pain intensity
Time frame: Postoperative day 1
Postoperative pain intensity
Time frame: Postoperative day 7 +/-7 days
Postoperative pain intensity
Time frame: Postoperative day 14 +/-7 days
Postoperative pain intensity
Time frame: postoperative day 21 +/-7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No. No plans to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Ghaznavi, MD principal investigator
Cleveland Clinic Florida, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepectoral approach and Partial Subpectoral approach in people with Breast Reconstruction Following Mastectomy, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction as measured by BREAST-Q-scores (time frame: Preoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.