Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
试验速览
- 阶段
- 3 期
- 入组人数
- 86
- 试验地点
- 2
- 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 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
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), both 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).
结局指标
主要结局
Rate in percentage of surgical complications
时间窗: 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
时间窗: 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.
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 for scoring(at 2 years from mastectomy)
- 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)
研究者
Kovacs
PhD, FRCS
Guy's and St Thomas' NHS Foundation Trust