跳至主要内容
临床试验/NCT06007599
NCT06007599Enrolling By Invitation不适用

Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
216
试验地点
2
主要终点
Patient satisfaction

研究概览

简要总结

Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
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

入选标准

  • Patients older than 18 years old that will undergo primary TKA with a midline approach

排除标准

  • Previous knee arthroplasty surgeries or midline scars
  • TKA secondary to oncologic or traumatic etiologies
  • uncontrolled diabetes (measured by a Hgb A1c above 8)
  • reported allergy to skin adhesive
  • immunodeficiencies
  • bleeding disorders
  • anticoagulation other than ASA

结局指标

主要结局

Patient satisfaction

时间窗: 90 days

Assessed using the POSAS (patient and observer scar assessment scale) questionnaire

wound complications

时间窗: 90 days

Assessed using Photographic documentation of the wound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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