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临床试验/NCT06576869
NCT06576869已完成不适用

"Timing Of Tourniquet Release, A Prospective Randomized Trial"

Orlando Health, Inc.2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2022年6月2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
214
试验地点
2
主要终点
Visual analog pain scale

研究概览

简要总结

This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. The study will compare objective data obtained intraoperatively as well as standard clinical outcome measures such as pain scores at routine follow up.

详细描述

Patients will be enrolled prior to surgery and consented to participate in the study [HPJ2]. Patients will be enrolled by the research staff with a provider including attending and resident surgeons as well as advanced practiced providers that are assigned to the upper extremity team. A computerized random number generator will be used to randomize patient allocation to either study arm: closure without releasing the tourniquet vs releasing the tourniquet and then closing the incision. Randomization will occur at the time of surgery. In order to standardize the procedure a 4-inch ace wrap will be wrapped around the upper arm and a tourniquet will be placed over this in order to ensure adequate padding [HPJ3] [AW4]. At the conclusion of the surgical procedure but prior to skin closure, the randomized number will be revealed to the surgeon and the surgeon will either release the tourniquet or will keep the tourniquet inflated and then close the skin. After the surgery is completed, information will be collected on the intraoperative data collection form to include: • Length and exact location of incision• Whether the patient is on anticoagulant medication., o This includes type/dose of medicationo Duration for taking the medicationo Was the medication halted prior to surgery; if so, when• Surgeon performing the surgery• Surgical procedure• Surgery location (Ambulatory Care Center (ACC), Orlando Regional Medical Center (ORMC), etc.) • When tourniquet is dropped (before/after closure)• Tourniquet Time• Time from tourniquet release to closure• Total Surgical time (time from incision until complete skin closure) • Turnover time• Was electrocautery required to control any bleeding; if so, what type and what was electrocauterized? Clinical outcome measures collected during postoperative follow up. • Visual analog pain scale• Quick Disability of the Arm, Shoulder and Hand (DASH) form• Complications including hematoma size• Satisfaction with treatment (scale 1-5)o completely satisfied - 5, somewhat satisfied - 4, neither satisfied or dissatisfied - 3, partly dissatisfied - 2, completely dissatisfied - 1• Likely to recommend this surgery to a friend family member who has the same condition - yes or no Patients enrolled in the study will follow up in clinic at the following time intervals: 2 weeks, 10 weeks, and 6 months per standard of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • Consented study subjects 18 years or older
  • Subjects with any upper extremity injury or ailment that would require the use of a tourniquet while doing surgery
  • Subject undergoing surgery by one of the six fellowship trained Orlando Health upper extremity surgeons previous listed
  • Subject without prior surgery to the operative extremity

排除标准

  • Subject under the age of 18 at the time of consent/enrollment
  • Subject has had previous surgical procedures at the surgery site
  • Subject with bleeding disorder comorbidities
  • Subjects who have tourniquet released and then re-inflated during their procedure
  • Subjects who do not have English as their preferred language and require an interpreter.

结局指标

主要结局

Visual analog pain scale

时间窗: 2 weeks, 10 weeks and 6 months.

Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain

Quick DASH form

时间窗: 2 weeks, 10 weeks, 6 months.

Assessment of symptoms and ability to perform certain activities.

Hematoma assessment

时间窗: 2 weeks, 10 weeks, 6 months.

Performed by MD, assessment of the presence of a hematoma and if present, it is measured.

Satisfaction with surgery

时间窗: 2 weeks, 10 weeks, 6 months.

Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition.

Visual analog pain scale

时间窗: 2 weeks, 10 weeks and 6 months.

Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain

Quick DASH form

时间窗: 2 weeks, 10 weeks, 6 months.

Assessment of symptoms and ability to perform certain activities.

Hematoma assessment

时间窗: 2 weeks, 10 weeks, 6 months.

Performed by MD, assessment of the presence of a hematoma and if present, it is measured.

Satisfaction with surgery

时间窗: 2 weeks, 10 weeks, 6 months.

Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition.

次要结局

未报告次要终点

研究者

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

Brett Lewellyn

Principal Investigator

Orlando Health, Inc.

研究点 (2)

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