Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 5
- 主要终点
- The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary.
研究概览
简要总结
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
详细描述
OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.
STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.
TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).
Method of assigning patients to treatment groups:
After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
- •Patient agrees to participate in study and to sign an informed consent form
- •Able and willing to return for all scheduled and required study visits
排除标准
- •Is a smoker (patient having quit at least 4 weeks prior surgery can be included)
- •BMI <18 or > 30
- •Previous radiation therapy to the region at any time
- •Insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
- •Predicted implant size <200 or >600 ml per investigator assessment
- •Allergy to porcine
- •Pregnancy or lactating
- •Current enrollment or plans to enroll in another clinical trial unless a retrospective study
- •Neoadjuvant treatment with chemotherapy
研究组 & 干预措施
Breast reconstruction with ADM
Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.
干预措施: Reconstruction with ADM. (Procedure)
Breast reconstruction with ADM
Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.
干预措施: Skin or nipple sparing mastectomy (Procedure)
Breast reconstruction with ADM
Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.
干预措施: Reconstruction with implant (Procedure)
Breast reconstruction with ADM
Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.
干预措施: Partial submuscular coverage (Procedure)
Breast reconstruction without ADM
Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.
干预措施: Skin or nipple sparing mastectomy (Procedure)
Breast reconstruction without ADM
Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.
干预措施: Reconstruction with implant (Procedure)
Breast reconstruction without ADM
Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.
干预措施: Total submuscular coverage (Procedure)
结局指标
主要结局
The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary.
时间窗: 24 months
Follow-up time after primary surgery is 24 months.
次要结局
- Aesthetic outcome(24 months)
- Cost-Benefit analysis(24 months)
- Complications(24 months)
- Number of surgical procedures(24 months)
- Quality of Life(24 months)
研究者
Fredrik Lohmander
Fredrik Lohmander MD
Karolinska University Hospital