Optimization Program for the Care Management of Wounds With Delayed Healing Risk After Hip Arthroplasty Based on TIME CDST Tool: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 492
- 主要终点
- Wound healing time
研究概览
简要总结
this study aims to optimize the components of TIME CDST based on clinical practice and apply the optimized elements to the management of wounds with delayed healing risk after hip arthroplasty to identify and design the key steps in the clinical application of TIME CDST. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of postoperative wounds with delayed healing risk in clinical practice, thereby improving patient outcomes and quality of life.
详细描述
- Research Background and Objectives Orthopedic surgical wounds present more complex healing challenges compared to other surgical wounds. Hip arthroplasty is the most common type of orthopedic surgery. Due to surgical complexity or patient-specific factors, this procedure is particularly prone to surgical complications such as surgical site infection, wound dehiscence, tissue necrosis, and hematoma, thereby increasing the risk of delayed wound healing postoperatively.To improve the healing outcomes of postoperative wounds with delayed healing, optimizing nursing management protocols is crucial. This study aims to optimize nursing management for wounds with delayed healing risk after hip arthroplasty using the TIME CDST tool and validate its effectiveness.
- Research Methods Study Design: This study employed a randomized controlled trial design, randomly assigning participants to an experimental group and a control group, which received different nursing management protocols.
Sample Size: A total of 492 patients are expected to be included, with 246 in the experimental group and 246 in the control group.
Intervention Measures: Patients in the experimental group will receive nursing management based on the TIME CDST tool, while those in the control group will receive conventional nursing management.
Evaluation Indicators: The primary outcome measure is wound healing time. Secondary outcome measures include the number of cases with wound healing, wound area reduction rate, ASEPSIS wound scoring system, Stone-Brock Scar Scoring Scale (SBSES), Visual Analog Scale (VAS), patient comfort score, patient satisfaction score, albumin levels, dressing change frequency, and medical costs.Clinical adverse events will be recorded for safety assessment.
Data collection and analysis: Data will be collected through questionnaire surveys, observation records, statistical analysis, and comparative analysis. 3. Study process Screening and grouping: Patients meeting the inclusion criteria will be screened and randomly assigned to the experimental group and control group.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •First-time recipient of unilateral total HA or hemiarthroplasty;
- •Postoperative wound healing delay risk, defined as epithelialization <50% at 2 weeks postoperatively (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a standardized transparent grid membrane with 1mm² graduations is placed vertically over the wound, and the wound perimeter and epithelialization boundary are marked with a surgical marker. boundary are marked with a surgical marker pen; the epithelialized area is defined as pink, non-exudative tissue completely covering the dermis); Normal cognitive and communication abilities;
- •Ability to comply with relevant nursing measures;
- •Voluntary participation in this trial
- •Voluntary participation in this trial and signed informed consent form.
排除标准
- •Active infection at the surgical site prior to initial hip surgery; Deep surgical site infection (SSI) or periprosthetic joint infection (PJI) diagnosed or strongly suspected at screening. diagnosed or strongly suspected at screening (based on clinical symptoms, imaging, or aspiration results according to the MSIS/EBJIS criteria);
- •Complete wound dehiscence (>2 cm) or exposure of the prosthesis/bone cement, requiring emergency revision surgery;
- •Severe vascular insufficiency (ABI <0.5 cm);
- •Severe acute and chronic chronic disease (ABI <0.5 cm) insufficiency (ABI <0.6, severe limb ischemia);
- •Uncontrolled systemic conditions severely impairing healing potential: severe malnutrition or obesity (BMI≥ 40 kg/m² or≤ 16 kg/m² or serum albumin <2.5 g/dL); Uncontrolled diabetes (HbA1c >9% in the past 3 months); severe heart failure (NYHA IV); severe liver dysfunction (Child-Pugh C); severe renal failure requiring dialysis; active malignant tumors; immunosuppressive therapy (high-dose corticosteroids >10 mg prednisolone); and dose corticosteroids >10 mg prednisone equivalent/day, biologics, or immunosuppressive agents following transplantation).
结局指标
主要结局
Wound healing time
时间窗: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Wound healing time will be assessed as the primary outcome indicator. Complete epithelialization of the wound is considered as wound healing and the time taken from enrollment to complete wound healing will be recorded for both groups.
Wound healing time
时间窗: The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.
Wound healing time will be assessed as the primary outcome indicator. Complete epithelialization of the wound is considered as wound healing and the time taken from enrollment to complete wound healing will be recorded for both groups.
次要结局
- Number of cases with wound healing(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Patient comfort score(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Patient satisfaction score(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Albumin levels(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The frequency of dressing changes(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Medical expenses(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The rate of wound area reduction(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- ASEPSIS wound scoring system(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Stony Brook Scar Evaluation Scale (SBSES)(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The pain intensity(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Number of cases with wound healing(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The rate of wound area reduction(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- ASEPSIS wound scoring system(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Stony Brook Scar Evaluation Scale (SBSES)(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The pain intensity(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Patient comfort score(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Patient satisfaction score(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Albumin levels(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- The frequency of dressing changes(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
- Medical expenses(The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.)
研究者
Danni Feng
Principal Investigator
Tongji Hospital