Immediate Implant Breast Reconstruction (ISIS)

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Terminated

Conditions

Breast Cancer

Treatments

Procedure: immediate implant breast reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02055937

2012-A01369-34 (Registry Identifier)

VA2012/37

Details and patient eligibility

About

The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

Full description

non applicable

Enrollment

53 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed breast carcinoma
Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
Patients planned to receive postoperative chest wall irradiation
Age ≥ 18 years old
WHO performance status 0-1
Affiliation to a social security system
Informed consent signed prior any study specific procedures

Exclusion criteria

Inflammatory breast cancer
Tumors with extensive involvement of the skin
Use of tissue expander
Indication of postoperative chemotherapy
Patients planned for bilateral mastectomy
History of previously treated ipsilateral breast carcinoma
Usual contraindications for ADM
Medical debility precluding surgical treatment
Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
Pregnancy or breast feeding
Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
Legal inability or restricted legal ability