Pre-pectoral Breast Reconstruction PART 2 (PreBRec)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast); Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

Study type: Interventional

Funder types: Other

Identifiers

NCT02831426

RCTBU022016

Details and patient eligibility

About

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.

Full 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

Enrollment: 86 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

ADM two-stage reconstruction

Active Comparator group

Description:

Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM

Treatment:

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

TCPM two-stage reconstruction

Experimental group

Description:

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

Treatment:

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