Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Breast Q
研究概览
简要总结
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 is at least 18 years of age
- •Patient is female
- •Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
- •Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy & reconstruction)
- •Patient utilized a textured expander only
- •Patient utilized a smooth gel permanent implant only
- •Patient has agreed and is able to comply with the study follow-up requirements
- •Patient or guardian has provided consent for participation
排除标准
- •Patient is undergoing single-stage breast reconstruction
- •Patient is undergoing a delayed reconstruction
- •Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
- •Patient is undergoing planned reconstruction using autologous tissue
- •Patient has a known hypersensitivity to collagen or bovine derived materials
- •Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study
- •Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
研究组 & 干预措施
No Intervention
Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
干预措施: No Intervention (Other)
SurgiMend® PRS (ADM)
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
干预措施: SurgiMend® PRS (Device)
结局指标
主要结局
Breast Q
时间窗: 12 months Post-Exchange
No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p. Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture.
Capsular Contracture Rate
时间窗: 12 months Post-Exchange
Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange
次要结局
- Total number of OR procedures(12 month follow-up visit)
- Total number of visits(12 month follow up visit)
- No. Capsule Procedures(12 months Post-Exchange)
- Cosmetic Assessment(12 months Post-Exchange)
- Time to Completion(12 months Post-Exchange)