Pre-pectoral Breast Reconstruction PART 2

NCT02831426 | Unknown Phase 3

• 1 other identifier: RCTBU022016
• Study Type: interventional
• Target: 86
• 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

Outcome Measures

Primary Outcomes (2)

• Rate in percentage of surgical complications

  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

  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 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 for scoring

  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)

  at 2 years from mastectomy

Other Outcomes (2)

• Cost-efficiency analysis with comparison of cost in money of the two arms

  at 3 years from mastectomy

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

  at 3 years from mastectomy

Study Arms (2)

ADM two-stage reconstruction

ACTIVE COMPARATOR

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)

TCPM two-stage reconstruction

EXPERIMENTAL

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)

Interventions

Two-stage with Acellular Dermal Matrix (CELLIS® Breast) DEVICE

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.

Also known as: Tissue Expander two-stage reconstruction with ADM, Tissue Expander / Implant exchange, Fat grafting

ADM two-stage reconstruction

Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) DEVICE

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.

Also known as: Tissue Expander two-stage reconstruction with TCPM, Tissue Expander / Implant exchange, Fat grafting

TCPM two-stage reconstruction

Eligibility Criteria

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

You may qualify if:

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

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tissue Expansion Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Tibor Kovacs, 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: PhD, FRCS

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 13, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

GB (1)