Evaluation of the Effectiveness of Prepectoral Breast Reconstruction
August 23, 2023 updated by: European Institute of Oncology
Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients.
The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.
Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.
Study Type
Interventional
Enrollment (Estimated)
58
Phase
- 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 Locations
-
-
-
Milan, Italy, 20141
- European Institute of Oncology
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Informed consent
- Not smokers
- No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
- BMI<30
- CUP B-C (or mastectomy estimated weight less than 550gm)
- Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)
- No previous breast surgery
- No previous breast irradiation
- Breast Ptosis 1-2 according to Renault's classification
- DCIS tumors
- T1 T2 pN0 breast tumor with known favourable biologic features
Exclusion Criteria:
- Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
- Positive sentinel node biopsy requiring complete axillary dissection
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prepectoral reconstruction
Prepectoral breast reconstruction with Braxon dermal matrix
|
Prepectoral breast reconstruction
|
|
Active Comparator: Submuscular reconstruction
Submuscolar breast reconstruction
|
Submuscolar breast reconstruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction assessed by the BREAST-Q
Time Frame: 1 year
|
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate complications rate
Time Frame: 1 month
|
Compare post operative complications
|
1 month
|
|
Short term complications rate
Time Frame: 6 months
|
Compare short term post operative complications
|
6 months
|
|
Long term complications rate
Time Frame: 24 months
|
Compare long term post operative complications
|
24 months
|
|
Percentage of capsular contracture
Time Frame: 1 year
|
Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francesca De Lorenzi, PhD, MD, European Institute of Oncology
- Principal Investigator: Paolo Veronesi, MD, European Institute of Oncology
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 (Actual)
September 3, 2019
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
November 17, 2021
First Posted (Actual)
November 18, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IEO 1002/
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.