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临床试验/NCT03512470
NCT03512470已完成不适用

A Clinical Study, Spontaneous, Randomized and Controlled, on the Prevention of Surgical Wound Complications for Aneurysmal Thoracoabdominal Aortic Disease by Using the "PREVENA ™" Negative Topical Pressure System (TVAC STUDY)

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Reduction of surgical site infections

研究概览

简要总结

The patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use.

The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).

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
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 over 18 years;
  • patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study.
  • patients with surgical wounds to treat thoracic-abdominal aortic pathology.

排除标准

  • patients with established sepsis;
  • patients with septic recurrence;
  • patients with sensitivity to silver.

结局指标

主要结局

Reduction of surgical site infections

时间窗: 14 days after surgery

Decrease in the percentage of surgical site infections and / or surgical wound dehiscence within 14 days of surgery

次要结局

  • Reduction of adverse events(12 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baccellieri Domenico

Principal Investigator

IRCCS San Raffaele

研究点 (2)

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