NCT05598801已完成不适用
A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand
Research Source1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年9月1日最近更新:
适应症
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
- Number of participants diagnosed with post-operative tenolysis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the hand/fingers, including tendon repair, fracture repair, or tenolysis of the hand/fingers. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively
详细描述
This is a prospective, post-market, observational, single center study evaluating the use of VersaWrap. Patients identified by the Investigator in his practice as needing surgery of the hand/fingers and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-70 at the time of surgery
- •Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance.
排除标准
- •Non-English speaking
- •Known allergy or sensitivity to citrate, alginate or hyaluronate
- •Pregnant or breastfeeding
- •Currently a prisoner
- •Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
结局指标
主要结局
Number of participants diagnosed with post-operative tenolysis
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract ExtractionCataractAphakiaNCT01230060Bausch & Lomb Incorporated122
已完成
不适用
Ventral Hernia Study Using OviTex Reinforced BioscaffoldHernia, VentralNCT03074474Tela Bio Inc92
已完成
不适用
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP CompositeHerniaNCT01305473C. R. Bard90
已完成
不适用
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia PatchVentral HerniaNCT00866814C. R. Bard119
终止
不适用
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound ComplicationsWound Infection, SurgicalPostoperative ComplicationsObesityNCT02461433Johns Hopkins University2