Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Postoperative Complication rates
研究概览
简要总结
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.
Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.
排除标准
- •Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.
研究组 & 干预措施
Subcuticular Suture Group
Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group.
干预措施: Subcuticular Suture (Procedure)
Simple Interrupted Suture Group
Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group.
干预措施: Simple Interrupted Suture (Procedure)
结局指标
主要结局
Postoperative Complication rates
时间窗: 2 and 8 weeks post-op.
Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.
次要结局
- Patient and Observer Scar Assessment Scale (POSAS)(2 and 8 weeks post-op.)
- Self-reported foot and ankle score (SEFAS)(2 and 8 weeks post-op.)