NCT01914653已完成不适用
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
Sofregen Medical, Inc.1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence of Implant Loss
研究概览
简要总结
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
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
- •To be eligible for enrollment, the subject must:
- •Be female, ≥ 18 years of age
- •If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care
- •Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
- •Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
- •Be eligible to enroll in one of the following three cohorts:
- •Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction;
- •Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction;
- •Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction.
排除标准
- •To be eligible for enrollment, the subject must not:
- •Have collagen-vascular, connective tissue, or bleeding disorders
- •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
- •Have a BMI that is ≥ 32
- •Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
- •Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
- •Be pregnant, lactating, or expecting to be within the next 24 months
- •Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
- •Require the use of any additional implant for soft tissue support of the contralateral non-study breast, except in bilateral breast reconstructions, where the use of SERI® Surgical Scaffold is allowed
- •Have had a prior soft tissue support implant
- •If enrolled into the Pre-Radiated cohort, have had recent radiation (< 1 year) to the breast/chest wall
- •If enrolled into the Post-Radiated cohort, radiation to the breast/chest wall is planned more than 1 year from the time of SERI® Surgical Scaffold placement
- •Have clinical evidence of severe radiation tissue damage (e.g. pigmentation, indentation, atrophy, no elasticity to skin of radiated breast) from previous XRT to the breast/chest wall
- •Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps
研究组 & 干预措施
Post-radiated
Experimental
干预措施: Silk surgical mesh (Device)
Pre-radiated
Experimental
干预措施: Silk surgical mesh (Device)
Not radiated
Experimental
干预措施: Silk surgical mesh (Device)
结局指标
主要结局
Incidence of Implant Loss
时间窗: 24 months postoperatively
Implant Loss will be defined as situations in which the breast implant is removed and not immediately replaced.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia RepairVentral Hernia RepairNCT01981044Sofregen Medical, Inc.1
已完成
不适用
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation SurgerySubjects Requiring Revision Breast Augmentation SurgeryNCT02030938Sofregen Medical, Inc.34
已完成
不适用
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction SurgeryBreast ReconstructionNCT01256502Sofregen Medical, Inc.160
已完成
不适用
Soft Tissue Graft for Repair of Pelvic Organ ProlapsePelvic Organ ProlapseNCT01827774Cook Group Incorporated31
已完成
不适用
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in EuropeSoft Tissue Support and RepairNCT01389232Sofregen Medical, Inc.104