The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.
研究概览
简要总结
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.
Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.
AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
- •Patients ≥ 21 and ≤ 75 years of age
排除标准
- •Patient refusal
- •Patients who will undergo any of the following:
- •Single-stage implant reconstruction
- •Combined autogenous tissue expander/implant reconstruction
- •Patients with a history of prior irradiation
- •Patients with a history of prior surgery with breast implants
- •Patients with a history of prior axillary lymph node dissection
- •Patients who are pregnant
- •The following eligibility will be confirmed at the time of surgery.
- •Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
- •Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)
研究组 & 干预措施
A
Expander Placement WITH Alloderm
干预措施: Alloderm, Questionnaires (Procedure)
B
Expander Placement WITHOUT Alloderm
干预措施: Without ALLODERM, Questionnaires (Procedure)
结局指标
主要结局
whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.
时间窗: conclusion of the study
次要结局
- To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use.(conclusion of the study)
- To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.(conclusion of the study)
- To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction.(conclusion of the study)
- To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase.(conclusion of the study)
- To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.(conclusion of the study)