Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
研究概览
简要总结
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
排除标准
- •Patients with prior surgical wound dehiscence or infection
- •Patients with allergy to suture material
研究组 & 干预措施
STRATAFIX PDS and Monocryl suture
All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.
干预措施: STRATAFIX PDS and Monocryl suture (Device)
结局指标
主要结局
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
时间窗: 1 month
The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores \<10 will be considered healed.
次要结局
- Wound imaging at perioperative followup(1, 3 and 6 months)
- Wound revision strategy(up to 6 months)
- Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score(3 and 6 months)
- The Wound-Quality of Life (QOL) questionnaire score(1, 3 and 6 months)
- Intraoperative time required for wound closure(Immediately following surgery)
- Percent of participants positive for superficial surgical site infection (SSI)(Up to six months)
- Number of case deviations and descriptions from prescribed suturing paradigm(Immediately following surgery)
- Liker scale of patient satisfaction with wound(1, 3 and 6 months)
研究者
Michael Karsy
Assistant Clinical Professor of Neurosurgery
University of Michigan