A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
研究概览
简要总结
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before and during dressing removal on the last visit
详细描述
A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.
Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.
100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •, enrolment phase
- •Age ≥ 18 years
- •Have an expected total length of stay of 4 postoperative days or more
- •Plan for elective primary arthroplasty of the hip or knee
- •Plan for incision size > 18 cm
- •Give their written informed consent to participate
- •Inclusion Criteria, randomization phase
- •Undergoing elective primary arthroplasty of the hip or knee
排除标准
- •,enrolment phase
- •Known allergy or hypersensitivity to any of the components of the dressings
- •Multitrauma
- •Undergoing arthroplasty due to tumour
- •Wound at the surgical site prior to surgery
- •Neurological deficit of operated side ,hemiplegia, etc.
- •Documented skin disease at time of enrolment, as judged by the investigator
- •Previously enrolled in the present investigation
- •Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator
- •Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.
- •Exclusion Criteria, randomization phase
- •Dressing size does not fit the incision area, over 18 cm
- •Complications that would increase wound risks if investigation dressing is applied
- •Postoperative drain
研究组 & 干预措施
Device Aquacel Surgical
Aquacel Surgical is a sterile, one piece post-operative dressing from Convatec.
Duration of treatment:
Total 5 days included the day of surgery and 4 post-operative days.
干预措施: Experimental: Mepilex Border Post-Op (Device)
Device Mepilex Border Post-Op
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Duration of treatment:
Total 5 days included the day of surgery and 4 post-operative days.
干预措施: Active Comparator: Aquacel Surgical (Device)
结局指标
主要结局
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
时间窗: 0-5 days
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
次要结局
- Dressings Adherence to the Staples/Sutures(0-5 days)
- Patients Satisfaction With Wearing the Dressing(0-5 days)
- Nurses/Doctors Satisfaction With Applying the Dressing(0-5 days)
- Itching Feeling Under the Dressing(0-5 days)
- Patients Mobility After Operation(0-5 days)
- Local/Systemic Infection(0-5 days)
- Pain Level Before and During Dressing Removal(Day 7)