Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in DIRECT-TO-IMPLANT (DTI) Pre-pectoral Implant Based Breast Reconstruction
试验速览
- 阶段
- 3 期
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Rate in percentage of surgical complications
研究概览
简要总结
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.
详细描述
This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:
the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM
- •Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
- •Prophylactic and therapeutic.
- •Included patients baseline characteristics will be:
- •Age 18-80 years old
- •BMI between 18.5 and
- •Former smokers (up until 3 weeks before surgery)
- •Hypertension at oral medications
- •Previous breast surgery
- •Previous breast and chest wall radiation therapy will be allowed.
排除标准
- •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).
研究组 & 干预措施
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)
干预措施: DTI with Acellular Dermal Matrix (CELLIS® Breast) (Device)
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
干预措施: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) (Device)
结局指标
主要结局
Rate in percentage of surgical complications
时间窗: up to 6 months
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.
Rate in percentage of technique failure
时间窗: up to 6 months
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).
次要结局
- Objective quality of life assessment with Baker scale for capsular contracture(at 2 years from mastectomy)
- Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring(at 2 years from mastectomy)
- 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).(at 2 years from mastectomy)
研究者
Kovacs
MD, PhD
Guy's and St Thomas' NHS Foundation Trust