Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time for Incision Closure
研究概览
简要总结
The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.
The objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. A single fellowship trained shoulder surgeon will perform all procedures. It is hypothesized that participants who undergo an 2-Octyl Cyanoacrylate (OCA) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance.
Participants in the OCA mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. This investigation seeks to determine if OCA closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance.
If the hypothesis is confirmed, this study will suggest that a OCA mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Sealed envelop determining which arm the participant is assigned to
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Total shoulder arthroplasty
- •Reverse total shoulder arthroplasty
- •Age 18-100
- •Single Surgeon
排除标准
- •Previous shoulder surgery
- •Known wound healing complications
- •DM, chronic steroid use, vascular insufficiency, morbid obesity (BMI>40), ESRD, family hx of pathologic scars
- •Patients on blood thinners (ASA 81mg ok)
- •Connective tissue disease
- •Allergy to skin adhesive
- •Mentally unable to complete questionnaires
- •Previous wound over planned incision
结局指标
主要结局
Time for Incision Closure
时间窗: During surgery (approximately 40 minutes)
A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision.
次要结局
- Cost of Closure(Immediately post surgery)
- Number of Wounds That Require Post Operative Intervention(At each follow up visit up to 3 months after surgery)
- Wound Appearance(At each follow up visit up to 3 months after surgery)
- Dehiscence(At each follow up visit up to 3 months after surgery)
- Wound Drainage(At first post operative visit)
- Deep Wound Infection(At each follow up visit up to 3 months after surgery)
- Superficial Infection(At each follow up visit up to 3 months after surgery)