- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831426
Pre-pectoral Breast Reconstruction PART 2 (PreBRec)
Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
Study Overview
Status
Conditions
Detailed Description
This phase III randomized clinical trial will be investigating the Two-stage, using Tissue Expander (TE) pre-pectoral reconstructions.
The trial will comprise two arms:
PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Tibor Kovacs, PhD, FRCS
- Phone Number: 07879408272
- Email: tiborkovacsdr@yahoo.co.uk
Study Contact Backup
- Name: Matthew Young, MSc
- Phone Number: 02071880743
- Email: matthew.young@gstt.nhs.uk
Study Locations
-
-
-
London, United Kingdom, SE1 9RT
- Breast Surgery Unit, Guy's and St Thomas' Hospital NHS Trust
-
Contact:
- Tibor Kovacs, MD
- Phone Number: 00447879408272
- Email: tibor.kovacs@gstt.nhs.uk
-
Sub-Investigator:
- Ashutosh Kothari, MD
-
Sub-Investigator:
- Claudio Calabrese, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic.
Included patients baseline characteristics will be:
- age 18-80 years old
- BMI between 18.5 and 35.
- Former smokers (up until 3 weeks before surgery)
- hypertension at oral medications
- diabetes
- previous breast surgery
- previous breast and chest wall radiation therapy will be allowed.
Exclusion Criteria:
- T4 and metastatic breast cancers
- obese patients (BMI over 35)
- currently smoking patients (within 3 weeks before surgery)
- refusal to sign the consent
- severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ADM two-stage reconstruction
Two-stage with Acellular Dermal Matrix (CELLIS® Breast).
Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM
|
After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position.
The tissue expander will be held in place by an ADM (CELLIS® Breast, MECCELLIS BIOTECH, 40 rue Chef de Baie, 17000, La Rochelle FRANCE) either completely wrapped around it or just covering its anterior surface.
After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole.
Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
Other Names:
|
Experimental: TCPM two-stage reconstruction
Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra).
Tissue Expander B, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by TCPM
|
After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position.
The tissue expander will be held in place by a Titanium Coated Polypropylene Mesh (TiLOOOP® Bra, pfm medical, ag Wankelstraße 60 ,50996 Köln GERMANY) either completely wrapped around it or just covering its anterior surface.
After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole.
Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate in percentage of surgical complications
Time Frame: up to 6 months
|
Surgical outcomes will be evaluated considering the rate in percentage of cases affected by the following complications among total number: surgical site infection (any infection requiring an antibiotic therapy, either oral or intravenous), wound dehiscence, seroma (any fluid collection requiring aspiration for more than a month from mastectomy), nipple/skin necrosis (either partial or complete), hematoma, red breast syndrome, with their reintervention rate. Rates will be compared between the two groups |
up to 6 months
|
Rate in percentage of technique failure
Time Frame: up to 6 months
|
The failure rate, as percentage, will be compared between the two arms: failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted. |
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective quality of life assessment with Baker scale for capsular contracture
Time Frame: at 2 years from mastectomy
|
Long-term outcomes, after two years from mastectomy and at least 3 months from TE/implant exchange, in quality of life will entail first of all an objective assessment: such evaluation will include the capsular contracture rate, with the assessment of the reintervention rate for amelioration or for a reconstructive strategy change.
Among these objective evaluations, any possible short-term complications after second-stage procedure will be investigated.
|
at 2 years from mastectomy
|
Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring
Time Frame: at 2 years from mastectomy
|
A third party objective evaluation will be carried out by a group of a surgeon, a nurse and a lay person from a different center from that one where every single case was performed.
This third party evaluation will assess the cosmetic outcome based on medical photographic files, giving a score for each patient.
Scores from the two arms will be compared.
|
at 2 years from mastectomy
|
Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved)
Time Frame: at 2 years from mastectomy
|
After 2 years from mastectomy and at least 3 months from TE/implant exchange a subjective evaluation will be carried out with BREAST-Q score (scores from the two arms will be transformed in 100 scale, summed and compared as median)
|
at 2 years from mastectomy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-efficiency analysis with comparison of cost in money of the two arms
Time Frame: at 3 years from mastectomy
|
Analysis of costs with comparison of the two arms will be carried out considering all costs from procedures and materials to possible late reinterventions to resolve complications and problems
|
at 3 years from mastectomy
|
Rate in percentage of complications in the sub-group of irradiated patients
Time Frame: at 3 years from mastectomy
|
An analysis of a specific subgroup of patients will be carried out, namely those previously submitted to a breast irradiation and those submitted to a post-mastectomy radiation therapy.
Analysis of short-terms failures and long-term problems with change in reconstruction strategy will be considered.
|
at 3 years from mastectomy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RCTBU022016
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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