Randomized Controlled Trial Comparing Nylon and Chromic Gut Sutures After Minor Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 6
- 主要终点
- Treatment satisfaction measured on an 11-point ordinal scale
研究概览
简要总结
This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.
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
- Double (Participant, Care Provider)
盲法说明
Both patient and surgeon will be blinded until just before the start of the procedure.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:
- •Carpal tunnel release
- •Trigger finger release
- •Ganglion excision
- •Excisional biopsy
- •De Quervain release
- •Dupuytren fasciectomy
- •Any other minor hand surgery
- •Patients aged 18-89
- •Able to provide informed consent
- •Able to understand English or Spanish to complete questionnaires
- •Patients who have an email-address or phone number (needed for follow-up)
- •UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Orthopaedic Specialists of Austin.
- •Available for follow-up contact after 4 weeks
排除标准
- •Patients not able to give informed consent
- •Patients using corticosteroids
- •Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
- •Patients known to be allergic to suture materials
- •Revision procedures
结局指标
主要结局
Treatment satisfaction measured on an 11-point ordinal scale
时间窗: Four weeks after surgery
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
次要结局
- Factors associated with wound concerns within one month of surgery(Four weeks after surgery)
- Factors associated with pain intensity (11 point ordinal scale) within one month of surgery(Four weeks after surgery)
- Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery(Four weeks after surgery)
- Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery(Four weeks after surgery)
- Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale(Four weeks after surgery)
研究者
David Ring
Associate Dean for Comprehensive Care. Professor of Surgery and Psychiatry
University of Texas at Austin