Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- Surgical site complication
研究概览
简要总结
This is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years or older
- •Scheduled to undergo primary hip or knee arthroplasty
- •Willing and able to comply with all study procedures and be available for the duration of the study
- •Provide signed and dated informed consent
排除标准
- •Unable to provide signed and dated informed consent
- •Unable or unwilling to comply with all study-related procedures
- •Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
- •Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections
- •Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
结局指标
主要结局
Surgical site complication
时间窗: within 12 weeks of the index procedure
Presence/absence of a surgical site complication. Surgical site complications to be defined as meeting at least one of the below criteria: 1. Bacterial or fungal infection as confirmed by PCR swabs 2. Hypertrophic scar formation as diagnosed by in-person assessment via the study investigator 3. Superficial granuloma formation as diagnosed by in-person assessment via study investigator 4. Wound dehiscence as diagnosed by in-person assessment via study investigator 5. Presence of discharge as diagnosed by in-person assessment via study investigator 6. Presence of wound redness as diagnosed by in-person assessment via study investigator 7. Presence of stitch abscess as diagnosed by in-person assessment via study investigator 8. Superficial surgical site infection as diagnosed by in-person assessment via study investigator in accordance with the NHSN SSI Checklist
次要结局
- Wound images(12 weeks after index procedure)
研究者
Giles Scuderi
Orthopaedic Surgery, Joint Reconstruction
Northwell Health