Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Condition: Breast Implant; Complications; Breast Implant Protrusion; Breast Cancer; Radiotherapy Side Effect
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Reconstructive surgery with breast implants after total mastectomy for breast cancer is
      invariably related to several possible complications, such as atrophy of surrounding tissues,
      skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such
      complications are promoted by elastic properties of tissues and their response to gravity
      forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic
      outcome may result up to breast implant exposure, and its removal may become necessary, thus
      compromising the quality of breast reconstruction. These complications are further favoured
      by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of
      peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and
      thinning. Since PMRT has been associated to improved loco-regional control in node-positive
      breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved
      loco-regional control but, on the other hand, it has increased the failure rate of breast
      reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate
      vs. two-staged by use of tissue expander) has not decreased the complications rate after
      PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT
      ranges from 0% to 40%. The present study will recruit 80 participants affected by breast
      cancer candidated to total mastectomy with immediate breast reconstruction and subsequent
      PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then
      definitive reconstruction with breast implant. Participants will be randomized in two
      experimental arms: 40 patients will receive final reconstruction by the use of standard
      silicone-based breast implant and the other 40 patients will receive B-Lite® light weight
      breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients
      will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the
      failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant
      removal). Secondary end-points include the overall complications rate, MRI evaluation of
      breast implant and surrounding tissues, cosmetic outcomes and quality of life including
      participants' satisfaction with breast reconstruction.
    


Intervention name(s): B-Lite® light weight breast implant; Standard silicone-based breast implant
Intervention type(s): Device; Device
Intervention description(s): Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant; Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment