Pre-pectoral Breast Reconstruction PART 1

Browse trials for

• Breast Neoplasms 12,815

Keywords

• pre-pectoral breast reconstruction
• subcutaneous breast reconstruction

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 131 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.

Study arms

• Active comparator
  Direct-To-Implant A

  DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM)

  Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)

• Experimental
  Direct-To-Implant B

  DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh

  Device: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

Interventions

• DeviceDTI with Acellular Dermal Matrix (CELLIS® Breast)

  After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

  Also known as: Pre-pectoral Direct-to-implant with ADM, fat grafting

• DeviceDTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)

  After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.

  Also known as: Pre-pectoral Direct-to-implant with TCPM, fat grafting

Primary outcomes

1. Rate in percentage of surgical complications

   Surgical outcomes within the first six months from mastectomy and IBBR will be evaluated with the statistical difference in percentage rate of complicated and non complicated patients between the two groups. Complications will be the following: 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, all in percentages.

   Time frame: up to 6 months

2. Rate in percentage of technique failure

   The failure rate will be assessed considering the statistical difference in percentage rate of removed implants among total number and comparing them between the two arms: in other words the prostheses (implants) loss rate (reinterventions with prosthesis removal).

   Time frame: up to 6 months

Secondary outcomes

1. Objective quality of life assessment with Baker scale for capsular contracture

   Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail first of all an objective evaluation: such evaluation will be performed with the the scoring of capsular contracture rate, including assessment of the reintervention rate for amelioration or for a reconstructive strategy change, comparing the two arms.

   Time frame: at 2 years from mastectomy

2. Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring

   In addition another objective analysis will include a third party objective evaluation, carried out by a group of a surgeon, a nurse and a lay person from a different center from that one where every single case was performed. This third party evaluation will assess the cosmetic outcome based on medical photographic files. Scores from this ranking will be compared between the two groups.

   Time frame: at 2 years from mastectomy

3. Subjective quality of life assessment using the BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved).

   Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail also a subjective evaluation: such evaluation will be carried out using the BREAST-Q questionnaire. Scores will be transformed in a 100 scale and compared as median between the two groups.

   Time frame: at 2 years from mastectomy

Other outcomes

1. Cost-efficiency analysis with comparison of costs in money of the two different procedures and following possible adjunctive costs for reintervention in case of complications

   A long-term evaluation of costs will be carried out for all cases, considering procedures, hospitalizations, days off from work and long-term readmission and revision surgeries. These data will be compared between arms and with every other type of reconstruction. A specific similar analysis will be conducted on irradiated cases comparing with non irradiated.

   Time frame: at 3 years from mastectomy

2. Rate in percentage of surgical complications in the sub-group of irradiated patients

   An analysis of the subgroup of patients with a previous breast irradiation or a post-mastectomy radiation therapy will be carried out considering short-term complications leading to failures and long-term complications leading to change in reconstruction strategy.

   Time frame: at 3 years from mastectomy