The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Vancouver Scar Scale
研究概览
简要总结
Scar is an unpleasant symptom that commonly appear after orthopedic surgery, especially the joint procedure. Due to the wide motion range, skin around joint has excessive tension that may increase risk for wide or conspicuous scar formation of surgical wound. Noticeable scar can negatively impact the quality of life and psychosocial development. However, scar management is overlooked in early recovery period easily. Patients commonly start to turn their attention to the surgical scar after the completion of rehabilitation or the resolution of disease or unbearable symptom. It is always beyond the best period of scar treatment, 3 to 6 months after wound healing. This study is aimed to observe and evaluate the scar formation with or without aggressive management in pediatric population within 6 months after wound healing.
详细描述
This is an observational, case-control study. Patients will be invited to participate and allocated to scar dressing group if they plan to use scar dressing. After gaining the written inform consent, participants will be asked to fulfill the patient diary, including the record of scar dressing use, patient scar assessment scale and satisfaction assessment, with parents' help. In regular group, patients are retrospectively selected by matched factors, such as demographics data. Scar-related data, including scar pictures, vancouver scar scale assessment and complication, are collected from medical history in both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 to 18 years
- •Had orthopedic surgery 3 weeks ago and within 6 weeks
- •Had incision sites around the knee
- •All surgical wounds healed completely
- •Length of surgical wounds between 2 and 15 centimeters
- •Planed to treat incisional scar with scar dressing, adhesive tapes, or adhesive strips
排除标准
- •Surgical wound infection
- •Atopic dermatitis or sensitive skin
- •Not able to make return visits regularly
- •Participation was not appropriate determined by physician
结局指标
主要结局
Vancouver Scar Scale
时间窗: 3 months after surgical wound healing
Vancouver scar scale includes four items toward evaluation of observable aspects of the scar. Each item is rated with 4-6 possible points.
次要结局
- Patient Scar Assessment Scale(From surgical wound healed to 6 months later)
- Patient satisfaction(3 months after surgical wound healing)
- Incidence of incision site complication(From surgical wound healed to 6 months later)