NCT02426762Unknown2 期
Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection
First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- freedom from surgical site infection
研究概览
简要总结
The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.
详细描述
- Study design: A prospective cohort study
- Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery.
- Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure.
- Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin.
- Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3).
- Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The informed consent has been obtained from the patient.
- •With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.
- •Endurable laparoscopic surgery without conversion.
- •With moderate/good ECOG health rating (PS): 0-1 score.
排除标准
- •Pregnant woman or lactating woman.
- •With confirmed distant metastasis in liver, lung, bones, or other organs.
- •Intolerable laparoscopic operation or converted to open surgery.
- •With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- •With bad compliance or contraindication to enrollment.
结局指标
主要结局
freedom from surgical site infection
时间窗: within the first 30 days after laparoscopic surgery
The study endpoint should be freedom from superficial surgical site infection (SSI) or deep SSI as defined by the Centers of Disease Control and Prevention National Nosocomial Infection Surveillance criteria.
次要结局
- Pain Scores on the Visual Analog Scale(within the first 30 days after laparoscopic surgery)
- Length of hospital stay(an expected average of 4 weeks)
研究者
Wu Song
Director of Center of Gastrointestinal Surgery
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip ArthroplastyMetastatic Bone Disease of the Proximal FemurNCT03746717Rigshospitalet, Denmark70
已完成
4 期
Tissue Sealant Use in LASIK Enhancement SurgeryEpithelial IngrowthNCT02952365Stanford University2
进行中（未招募）
不适用
Mepiform in Simultaneous Bilateral TKAScar PreventionNCT06312527Thammasat University Hospital30
已完成
不适用
The Use of Fibrin Sealant to Reduce Bleeding After Total Knee ReplacementTotal Knee ReplacementPrimary Knee ArthroplastyOsteoarthritis of the KneeNCT01816282University of Milan62
Unknown
不适用
Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery PatientsSurgical Wound InfectionsColorectal SurgeryNCT02143336Instituto de Investigación Hospital Universitario La Paz400