Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Incidence of surgery-related pressure injuries
研究概览
简要总结
The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.
详细描述
The goal of this clinical trial is to learn if applying soft foam dressings (AQUACEL Foam Hydrofiber Dressing) can prevent surgery-related pressure injuries in adult patients (≥18 years) undergoing cardiac surgery under general anesthesia with cardiopulmonary bypass (CPB). The main questions it aims to answer are:
Does the use of soft foam dressings reduce the incidence of perioperative pressure injuries compared with routine skin protection measures alone? Does the intervention delay the time to pressure injury development and improve postoperative skin integrity during the first 5 postoperative days? Researchers will compare the intervention group (routine prevention + AQUACEL Foam applied to high-risk pressure areas) to the control group (routine prevention only) to see if the foam dressing intervention reduces pressure injury occurrence after cardiac surgery.
Participants will:
Be screened for eligibility and provide written informed consent Receive either routine pressure injury prevention care alone (control group) or routine care plus AQUACEL Foam dressings (intervention group) applied to pressure-prone areas (e.g., heels, sacrococcygeal region, and hallux bony prominence) Complete a demographic questionnaire (approximately 10 minutes; self-completed or assisted by the researcher)
Undergo skin assessments 6 times:
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 (Participant)
盲法说明
All preventive measures will be applied after induction of anesthesia; therefore, participants will be unable to know which study group they are assigned to. In addition, the foam dressing and/or other protective measures will be removed at the end of surgery, further ensuring that participants remain unaware of their group allocation after the procedure.
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
- •Adults aged 18 years or older
- •Scheduled to undergo cardiac surgery under general anesthesia
- •Use of cardiopulmonary bypass (CPB) during surgery
- •Expected surgical duration greater than 4 hours
- •Intact skin without pre-existing pressure injury prior to surgery
排除标准
- •Surgical position other than supine
- •Long-term bedridden status prior to hospital admission
- •Altered consciousness or inability to cooperate
- •History of stroke with residual limb weakness
研究组 & 干预措施
Prophylactic soft foam Dressing
In addition to general routine skin protection measures, also add soft foam dressings.
干预措施: CONVAFoam Hydrofiber Dressing (Device)
Prophylactic soft foam Dressing
In addition to general routine skin protection measures, also add soft foam dressings.
干预措施: Standard Pressure Injury Prevention Care (Other)
Standard Pressure Injury Prevention Care
General routine skin protection measures (fatty pressure relief pads, cotton rolls or towels to isolate tubing, heel pads, etc.)
干预措施: Standard Pressure Injury Prevention Care (Other)
结局指标
主要结局
Incidence of surgery-related pressure injuries
时间窗: From preoperative baseline (before surgery) to postoperative day 5
The occurrence of new pressure injuries at any anatomical site, assessed using NPIAP staging criteria. Skin assessments will be performed by trained staff at predefined perioperative time points to determine whether a pressure injury develops after surgery.
次要结局
- Time to development of pressure injury(From end of surgery to postoperative day 5)
- Severity stage of pressure injuries(Postoperative day 1 to postoperative day 5)
研究者
Shih,Wen-Chi
Nurse
Fu Jen Catholic University Hospital