Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty: a Prospective, Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Infection control rate
研究概览
简要总结
The efficacy of using self-adhesive silicone gel waterproof dressings versus conventional gauze dressings for recovery after total joint arthroplasty (TJA) remains unclear. In our study, we conducted a prospective, randomized controlled trial to compare these two types of dressings. Patients were divided into two groups following TJA, and we collected primary outcome measures such as skin infection rate and re-operation rate. Additionally, we gathered blood inflammatory indicators, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), to evaluate the effectiveness of the two treatments. Finally, we perform one year follow up including REEDA score, MSS score to evaluate the recovery of the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old, gender is not limited;
- •Meet the diagnostic criteria for artificial joint replacement;
- •Initial joint replacement surgery;
- •Voluntary and signed informed consent.
排除标准
- •Allergic to self-adhesive silicone rubber waterproof dressing;
- •Patients with severe knee joint infection who cannot undergo artificial joint replacement;
- •Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
- •periprosthesis infection after multiple joint replacement;
- •Active infection at the site of intravenous or joint injection;
- •long-term use of anticoagulants or antiplatelet drugs due to other diseases;
- •Have sepsis or positive blood culture within the last 30 days;
- •Radiotherapy and chemotherapy are required due to neoplastic diseases;
- •Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
- •severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
- •Have a history of drug abuse;
- •Treatment of bone marrow or other transplants with immunosuppressive drugs;
- •Pregnant, parturient and lactating women;
- •Participating in other clinical trials;
- •Researchers believe that other reasons are not appropriate for clinical trial participants.
结局指标
主要结局
Infection control rate
时间窗: One month and three month after surgery
Calculate the infection control rate in the two groups
Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)
时间窗: One day before surgery, three month after surgery
The REEDA score is a clinical tool used to assess the healing of perineal wounds and other skin wounds, particularly after childbirth. REEDA stands for Redness, Edema, Ecchymosis, Discharge, and Approximation. Each of these five parameters is scored on a scale from 0 to 3, with higher scores indicating more severe symptoms. The total REEDA score can range from 0 to 15.
Modified Severity Score (MSS)
时间窗: One day before surgery, three month after surgery
This score is often used in dermatology to evaluate the severity of conditions such as atopic dermatitis or other chronic skin disorders. The MSS score helps clinicians to quantify the extent and severity of skin involvement, aiding in treatment decisions and monitoring progress.
次要结局
- American Knee Society Score (AKS score)(One day before surgery and three months after surgery.)
- Aspartate Aminotransferase (AST)(One day before surgery and one day after surgery)
- Blood Urea Nitrogen （BUN）(One day before surgery and one day after surgery)
- Alanine Aminotransferase (ALT)(One day before surgery and one day after surgery)
- X-ray(One day before surgery and three months after surgery.)
- The Harris Hip Score (HHS)(One day before surgery and three months after surgery.)
- Visual Analog Scale (VAS score)(One day before surgery and three months after surgery.)
- Serum Creatinine(One day before surgery and one day after surgery)
研究者
Long Hua
Principal Investigator
First Affiliated Hospital of Xinjiang Medical University