Pre-pectoral Breast Reconstruction PART 1

NCT ID: NCT02830685

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

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.

Detailed Description

This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:

the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct-To-Implant A

DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM)

Group Type: ACTIVE_COMPARATOR

DTI with Acellular Dermal Matrix (CELLIS® Breast)

Intervention Type: DEVICE

After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

Direct-To-Implant B

DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh

Group Type: EXPERIMENTAL

DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

Intervention Type: DEVICE

After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

Interventions

DTI with Acellular Dermal Matrix (CELLIS® Breast)

After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

Intervention Type: DEVICE

DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

Intervention Type: DEVICE

Other Intervention Names

Pre-pectoral Direct-to-implant with ADM, fat grafting; Pre-pectoral Direct-to-implant with TCPM, fat grafting

Eligibility Criteria

Inclusion Criteria

• Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Kovacs

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Breast Unit Surgery, Guy's and St Thomas' Hospital NHS Trust

London, , United Kingdom

Countries

United Kingdom

Central Contacts

Tibor Kovac, PhD, FRCS

Role: CONTACT

tiborkovacsdr@yahoo.co.uk

07879408272

Matthew Young, MSc

Role: CONTACT

matthew.young@gstt.nhs.uk

02071880743

Facility Contacts

Tibor Kovacs, MD

Role: primary

tibor.kovacs@gstt.nhs.uk

00447879408272

Other Identifiers

RCTBU012016

Identifier Type: -

Identifier Source: org_study_id