The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.
排除标准
- •Preoperative radiation therapy
- •Autoimmune disease
- •Uncontrolled diabetes mellitus
- •Inability to comprehend or cooperate with postoperative instructions
- •Local or systemic infection
- •Have any allergies to the excipient ingredients found in the matrix
- •Pregnancy
- •Low vascularity of the surrounding tissue
- •Mechanical trauma
- •Poor nutrition
- •Poor general medical condition
研究组 & 干预措施
Traditional Method
Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander
干预措施: Serratus anterior to cover lateral aspect of tissue expander (Procedure)
Dermamatrix Arm
Arm which uses Dermamatrix as the lateral expander coverage
干预措施: Dermamatrix to cover lateral aspect of tissue expander (Procedure)
结局指标
主要结局
postoperative pain
时间窗: perioperative up to 1 year
次要结局
- complications (infection, hematoma, capsular contracture)(1 year)
- Patient satisfaction(1 year)
- aesthetic outcome(1 year)