Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Overall handling
研究概览
简要总结
This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of intraoperative handling.
详细描述
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Enrollment
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Urologic surgery which needs fascia and subcutaneous tissue repairs
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Clean and clean-contaminated surgery
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Patients aged more than 18 years and under 80 years
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Randomization
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NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture
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Stratification by operative methods: Open surgery vs. laparoscopic or robot-assisted laparoscopic surgery
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Follow-up with 30 days
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Primary endpoint: intraoperative handling during operation
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Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and 11th (± 4) days
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Safety evaluation: counting adverse events within postoperative 30 days
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urologic surgery which needs fascia and subcutaneous tissue repairs
- •Clean and clean-contaminated surgery
排除标准
- •Contaminated surgery
- •Wound requiring retention suture
- •Suspicious malnutrition status
- •Active infection status or AIDS
- •Incision sites prone to expand, stretch, distend, or require support
- •Allergy or hypersensitivity to chlorhexidine diacetate
- •Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
研究组 & 干预措施
NEOSORB PLUS
Subjects who are treated by NEOSORB PLUS
干预措施: NEOSORB PLUS (Device)
NEOSORB
Subjects who are treated by NEOSORB
干预措施: NEOSORB (Device)
结局指标
主要结局
Overall handling
时间窗: During the operation
1 to 5 scale
次要结局
- Surgical hand(During the operation)
- Lack of fraying(During the operation)
- Knot tie-down smoothness(During the operation)
- Memory(During the operation)
- Healing progress, apposition(On postoperative 1st(+1) and 11th(±4) day)
- First-throw knot holding(During the operation)
- Ease of passage though tissue(During the operation)
- Pain(On postoperative 1st(+1) and 11th(±4) day)
- 30 days cumulative skin infection rate(Within postoperative 30 days)
- 30 days cumulative suture sinus (culture-negative) rate(Within postoperative 30 days)
- Knot security(During the operation)
- Infection(On postoperative 1st(+1) and 11th(±4) day)
- Suture sinus, culture-negative(On postoperative 1st and 11(± 4)th day)
- Erythema(On postoperative 1st(+1) and 11th(±4) day)
- Seroma requiring drainage(On postoperative 1st(+1) and 11th(±4) day)
- Edema(On postoperative 1st(+1) and 11th(±4) day)
- Skin temperative increase(On postoperative 1st(+1) and 11th(±4) day)
- 30 days cumulative seroma requiring drainage rate(Within postoperative 30 days)
- Adverse events(Within postoperative 30 days)
研究者
Chang Wook Jeong
Professor
Seoul National University Hospital