Aortic Aneurysm, Aortic Diseases, Aortic Dissection, AORTIC VALVE DISEASES, CABG, CAD - Coronary Artery Disease, Mitral Disease, Valve Disease, Heart, Valve Heart Stenosis
Conditions
Brief summary
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.
Detailed description
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: T0: during preoperative preparation T1: immediately after surgery T2-T5: once daily for 4 consecutive days after ICU transfer Have perioperative and clinical data collected from medical records (e.g., surgical duration, CPB time/temperature, laboratory values such as albumin, Hb, RBC, Hct, BUN, creatinine)
Interventions
DEVICECONVAFoam Hydrofiber Dressing
Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence)
OTHERStandard Pressure Injury Prevention Care
Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.
Sponsors
Shih,Wen-Chi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgery-related pressure injuries | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to development of pressure injury | From end of surgery to postoperative day 5 | The time (in days) from surgery completion to the first documented occurrence of a pressure injury. |
| Severity stage of pressure injuries | Postoperative day 1 to postoperative day 5 | The highest NPIAP stage of any pressure injury observed during the 5 postoperative days. |
Outcome results
None listed