Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
研究概览
简要总结
This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subjects will be included if:
- •They are 18 years or older;
- •They are undergoing primary total shoulder arthroplasty by the principal and co-investigator.
- •They are willing and have the capacity to provide informed consent;
- •They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC).
- •Subjects will be excluded if:
- •They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision
- •They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive;
- •They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach;
- •Their medical record shows that they are HIV positive or otherwise immunocompromised;
- •Their medical record shows a skin abnormality or dermatological condition which affects skin healing;
- •They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.
排除标准
- 未提供
研究组 & 干预措施
Traditional Dermabond + subcuticular sutures - Surgeon 1
Subcuticular sutures with traditional Dermabond applied to incision.
干预措施: Subcuticular Sutures - Surgeon 1 (Procedure)
Metal staples - Surgeon 2
Metal staples
干预措施: Metal Staples - Surgeon 2 (Procedure)
Dermabond PRINEO - Surgeon 1
Dermabond PRINEO System
干预措施: PRINEO - Surgeon 1 (Device)
Dermabond PRINEO - Surgeon 2
Dermabond PRINEO System
干预措施: PRINEO - Surgeon 2 (Device)
结局指标
主要结局
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
时间窗: 3 months post-operatively
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Mean Closure Time Per Centimeter of Incision
时间窗: Immediate/at time of surgery
This closure time was measured from the first stitch for closure to the application of the wound dressing. The incision length was measured immediately after closure.
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
时间窗: 3 months post-operative
Closure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.
次要结局
- Median Scar Assessment (POSAS) by Plastic Surgeon(Up to 3 months post surgery)
- Median Overall Opinion Score Reported by Operating Surgeon(Up to 3 months)
- Median Overall Opinion Score Reported by Plastic Surgeons(Up to 3 months)
- Wound Cosmesis (MHCS) Score by Plastic Surgeon(Up to 3 months post surgery)
- Median Wound Inflammation Score (AIRE) Reported by Operating Physician(Up to 3 months post surgery)
- Median Scar Assessment (POSAS) by Operating Surgeon(Up to 3 months post surgery)
- Wound Cosmesis (MHCS) Score by Operating Physician(Up to 3 months post surgery)
- Differences Between Patient and Surgeon Total POSAS Scores(3 months post-operatively)
研究者
Josef Eichinger
Professor
Medical University of South Carolina