Pre-pectoral Breast Reconstruction PART 2

Phase 3

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

• Registration Number: NCT02831426
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief 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

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-09
• Study First Posted: 2016-07-13
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03
• Study Start: 2017-01
• Primary Completion: 2019-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADM two-stage reconstruction	Two-stage with Acellular Dermal Matrix (CELLIS® Breast)	Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM
TCPM two-stage reconstruction	Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)	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

Primary Outcome Measures

Name	Time	Method
Rate in percentage of surgical complications	up to 6 months	Surgical outcomes will be evaluated considering the rate in percentage of cases affected by the following complications among total number: 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. Rates will be compared between the two groups
Rate in percentage of technique failure	up to 6 months	The failure rate, as percentage, will be compared between the two arms: failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted.

Secondary Outcome Measures

Name	Time	Method
Objective quality of life assessment with Baker scale for capsular contracture	at 2 years from mastectomy	Long-term outcomes, after two years from mastectomy and at least 3 months from TE/implant exchange, in quality of life will entail first of all an objective assessment: such evaluation will include the capsular contracture rate, with the assessment of the reintervention rate for amelioration or for a reconstructive strategy change. Among these objective evaluations, any possible short-term complications after second-stage procedure will be investigated.
Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring	at 2 years from mastectomy	A third party objective evaluation will be 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, giving a score for each patient. Scores from the two arms will be compared.
Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved)	at 2 years from mastectomy	After 2 years from mastectomy and at least 3 months from TE/implant exchange a subjective evaluation will be carried out with BREAST-Q score (scores from the two arms will be transformed in 100 scale, summed and compared as median)

Trial Locations

Locations (1)

Breast Surgery Unit, Guy's and St Thomas' Hospital NHS Trust; 🇬🇧 London, United Kingdom