A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of Participants With Damage to the Incision and Surrounding Skin
研究概览
简要总结
The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.
详细描述
This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA).
The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Available for a follow-up visit including dressing change 7 days after surgery
- •Plan for elective primary hip or knee arthroplasty
- •Plan for incision size ≤18 cm
- •Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
- •Undergoing elective primary arthroplasty of the hip or knee.
排除标准
- •Known allergy/hypersensitivity to any of the components of the dressing
- •Multi-trauma
- •Undergoing arthroplasty due to tumor
- •Previous incision at the same knee or same side of the hip
- •Wound at the surgical site prior to surgery
- •Neurological deficit of operated side (hemiplegia, etc.)
- •Documented skin disease at time of enrollment, as judged by the investigator
- •Previously enrolled in the present investigation
- •Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- •Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
- •Dressing size does not fit the incision area (>18 cm)
- •Complications that would increase wound risks if investigational dressing is applied
研究组 & 干预措施
Mepilex Border Post-Op Ag Dressing
A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
干预措施: Mepilex Border Post-Op Ag (Device)
结局指标
主要结局
Number of Participants With Damage to the Incision and Surrounding Skin
时间窗: Daily visits, up to 7 days
The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit
次要结局
- Number of Participants With Dressing Sticking to the Staples/Sutures(Daily visits, up to 7 days)
- Evaluation of the Dressing Capacity of Handling Blood(Daily visits, up to 7 days)
- Participants' Dressing Wear Time (Days)(7 days)
- Number of Participants With Bleeding Caused by Dressing Removal(Daily visits, up to 7 days)
- Number of Dressing Changes Per Subject(Daily visits, up to 7 days)
- Number of Participants With Leakage of the Dressing(Daily visits, up to 7 days)
- Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)(Daily visits, up to 7 days)