NCT02831426

Pre-pectoral Breast Reconstruction PART 2

Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-06-01
• Completion: 2020-12-01
• First posted: 2016-07-13
• Last updated: 2016-10-03

Locations

1 site across 1 country: United Kingdom