StASSH TRAUMA - St Andrew's Study for Sutures in Trauma Hand Surgery Non Absorbable vs Absorbable Sutures in Trauma Hand Surgery- Does Choice of Suture Material Impact Wound Healing, Complication Rates or Patient Symptoms?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 主要终点
- Infection rate %
研究概览
简要总结
An RCT will be set up to compare outcomes between two groups of hand surgery patients. These are:
• Emergency hand surgery patients - randomized to either absorbable or non-absorbable suture.
The primary outcomes investigated will be:
• Infection occurrence
The secondary outcomes will be:
- Scar appearance at 1 week and 6-8 weeks (assessed from photographs and scar scoring scale)
- Wound inflammation as a percentage of wound length at day 7 post surgery.
- Patient symptoms at 1 week (assessed from patient questionnaire)
- Patient symptoms at 6-8 weeks (assessed from patient questionnaire)
- QDASH Score at 1 week (assessed from patient questionnaire)
- QDASH score at 6-8 weeks (assessed from patient questionnaire)
- Occurrence of other complications (assessed from the above photographs, the above questionnaires and from nurse and doctor led reports of wound breakdown and other complications)
详细描述
SUMMARY OF TRIAL DESIGN
This is a single-center, single-blinded, RCT with a parallel-group design to compare two groups of hand surgery patients.
TRIAL SETTING
The RCT will be a single- blinded single centre trial run at St. Andrew's Centre for Plastic and Reconstructive Surgery, Broomfield Hospital (part of MSEFT). St. Andrew's Centre is one of the busiest centres in the UK and plastic and reconstructive surgeons with many thousands of hand surgeries taking place every year.
Recruitment and Invitation
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult emergency hand surgery patients (age 18-100) with suspected bone/tendon/nerve/blood vessel injury or high risk of infection e.g. bites
排除标准
- •Patients who are unable to consent or do not consent
- •Patients below the age of 18
- •Patients with a known allergy to vicryl rapide (polyglactin 910) or nylon (ethilon) suture.
- •Any patient whose hand surgery requires a skin graft.
- •Any patient operated on as an immediate emergency e.g. amputation, revascularisation.
结局指标
主要结局
Infection rate %
时间窗: 6-8 weeks
Infection rate %
次要结局
- Patient symptoms at 1 week(1 week)
- Scar appearance at 6-8 weeks(6-8 week)
- Patient symptoms at 6-8 weeks(6-8 weeks)
- Wound inflammation(1 week)
- Hand function at 1 week(1 week)
- Occurrence of any other complications(6-8 weeks)
- Scar appearance at 1 week(1 week)
- Hand function at 6-8 weeks(6-8 weeks)