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临床试验/NCT02779296
NCT02779296Unknown4 期

Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery

Ottawa Hospital Research Institute0 个研究点目标入组 30 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
30
主要终点
Surgical Site Infection

研究概览

简要总结

Surgical Site Infections (SSI) represents a significant complication in plastic surgery. Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One potential method to reduce infection is by applying a thin layer of dermal glue over the sutures at the site of incision immediately after the surgery. Conventional closures, such as sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48 hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been shown to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed in a vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to be more flexible than previous preparations. The application of dermal glue is rapid, simple and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection following surgery. Patients undergoing breast surgery will be recruited and randomized to either a group receiving a layer of glue over sutures following surgery or no treatment. Patients will be followed up at 30 days and at 8 months for signs of infection, additional complications and the visual appearance of the scars. The cost of treating and infection will be calculated to determine if using dermal glue to prevent infection is economically feasible. This research has the potential to find a method to reduce surgical site infection, which can be applied to other surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •patient has provided signed consent
  • •undergoing surgery on the breast

排除标准

  • •Infection within 30 days
  • •Previous hypersensitivity to cyanoacrylates or formaldehyde

研究组 & 干预措施

2-Octyl Cyanoacrylate Glue

Experimental

At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.

干预措施: 2-Octyl Cyanoacrylate Glue (Other)

No Glue

No Intervention

No cyanoacrylate glue will be applied.

结局指标

主要结局

Surgical Site Infection

时间窗: 30 days post surgery

次要结局

  • Other Surgical Complications(8 months post surgery)
  • Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0(8 months post surgery)
  • Cost Analysis to determine the cost to treat a patient with and without a surgical site infection(8 months post surgery)
  • Other Surgical Complications(30 days post surgery)
  • Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0(30 days post surgery)

研究者

申办方类型
Other
责任方
Sponsor

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