Pre-pectoral Breast Reconstruction PART 1

NCT02830685 | Unknown Phase 3

• 1 other identifier: RCTBU012016
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

pre-pectoral breast reconstruction; subcutaneous breast reconstruction

Outcome Measures

Primary Outcomes (2)

• Rate in percentage of surgical complications

  Surgical outcomes within the first six months from mastectomy and IBBR will be evaluated with the statistical difference in percentage rate of complicated and non complicated patients between the two groups. Complications will be the following: 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, all in percentages.

  up to 6 months

• Rate in percentage of technique failure

  The failure rate will be assessed considering the statistical difference in percentage rate of removed implants among total number and comparing them between the two arms: in other words the prostheses (implants) loss rate (reinterventions with prosthesis removal).

  up to 6 months

Secondary Outcomes (3)

• Objective quality of life assessment with Baker scale for capsular contracture

  at 2 years from mastectomy

• Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring

  at 2 years from mastectomy

• Subjective quality of life assessment using the BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved).

  at 2 years from mastectomy

Other Outcomes (2)

• Cost-efficiency analysis with comparison of costs in money of the two different procedures and following possible adjunctive costs for reintervention in case of complications

  at 3 years from mastectomy

• Rate in percentage of surgical complications in the sub-group of irradiated patients

  at 3 years from mastectomy

Study Arms (2)

Direct-To-Implant A

ACTIVE COMPARATOR

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

Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)

Direct-To-Implant B

EXPERIMENTAL

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

Device: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

Interventions

DTI with Acellular Dermal Matrix (CELLIS® Breast) 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.

Also known as: Pre-pectoral Direct-to-implant with ADM, fat grafting

Direct-To-Implant A

DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) 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.

Also known as: Pre-pectoral Direct-to-implant with TCPM, fat grafting

Direct-To-Implant B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

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

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Tibor Kovac, PhD, FRCS

CONTACT

07879408272; tiborkovacsdr@yahoo.co.uk

Matthew Young, MSc

CONTACT

02071880743; matthew.young@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 13, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

GB (1)