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Pre-pectoral Breast Reconstruction PART 2 (PreBRec)

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ClinicalTrials.gov Identifier: NCT02831426
Recruitment Status : Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Kovacs, Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast) Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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
Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast)
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:
  • Tissue Expander two-stage reconstruction with ADM
  • Tissue Expander / Implant exchange
  • Fat grafting

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
Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
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:
  • Tissue Expander two-stage reconstruction with TCPM
  • Tissue Expander / Implant exchange
  • Fat grafting




Primary Outcome Measures :
  1. 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


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)


Other Outcome Measures:
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831426


Contacts
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Contact: Tibor Kovacs, PhD, FRCS 07879408272 tiborkovacsdr@yahoo.co.uk
Contact: Matthew Young, MSc 02071880743 matthew.young@gstt.nhs.uk

Locations
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United Kingdom
Breast Surgery Unit, Guy's and St Thomas' Hospital NHS Trust
London, United Kingdom, SE1 9RT
Contact: Tibor Kovacs, MD    00447879408272    tibor.kovacs@gstt.nhs.uk   
Sub-Investigator: Ashutosh Kothari, MD         
Sub-Investigator: Claudio Calabrese, MD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust

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Responsible Party: Kovacs, PhD, FRCS, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02831426    
Other Study ID Numbers: RCTBU022016
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016