NCT05610267已完成不适用
A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
研究概览
简要总结
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
详细描述
Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
- •Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.
排除标准
- •Subject has known allergy to porcine-derived products.
- •Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
- •Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
- •Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.
- •Subject has been diagnosed with cirrhosis and/or ascites.
结局指标
主要结局
Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
时间窗: 90 days
Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure
次要结局
- Incidence of Surgical Site Infections (SSIs) Post Index Procedure(90 days)
- Incidence of Later Post-operative Complications After 90 Days Post Index Procedure(1 year)
- Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure(90 days)
- Incidence of Hernia Recurrence Confirmed by Clinical Assessment(1 year)
- Incidence of Reoperation Requirement Due to Index Repair(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
T-GENVIH-003 LTFU (Long Term Follow Up) StudyHernia, VentralPathological Conditions, AnatomicalHernia, AbdominalHerniaNCT06034652Integra LifeSciences Corporation8
已完成
不适用
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a WoundScarNCT01706848Halscion, Inc.60
已完成
不适用
A retrospective study to evaluate safety and utility of a newly designed large cell stent for endoscopic bilateral stent-in-stent placement in patients with malignant hilar biliary obstructioonresectable malignant hilar biliary obstructionJPRN-UMIN000010244Department of Gastroenterology and Hepatology, Hokkaido University Hospital30
已完成
不适用
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.Abdominal InjuryThoracic DiseasesNCT03515811Medtronic - MITG136
已完成
不适用
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical ExcisionEarlobe KeloidsNCT01706861Halscion, Inc.51