An interventional study of CONVAFoam Hydrofiber Dressing and Standard Pressure Injury Prevention Care in CAD - Coronary Artery Disease, CABG and Valve Disease, Heart, sponsored by Shih,Wen-Chi. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Shih,Wen-Chi · Not applicable, Interventional, and Prevention
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.
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)
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 80 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
In addition to general routine skin protection measures, also add soft foam dressings.
Device: CONVAFoam Hydrofiber Dressing · 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.)
Other: Standard Pressure Injury Prevention Care
Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence)
Also known as: CONVAfoam
Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.
Incidence of surgery-related pressure injuries
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.
Time frame: From preoperative baseline (before surgery) to postoperative day 5
Time to development of pressure injury
The time (in days) from surgery completion to the first documented occurrence of a pressure injury.
Time frame: From end of surgery to postoperative day 5
Severity stage of pressure injuries
The highest NPIAP stage of any pressure injury observed during the 5 postoperative days.
Time frame: Postoperative day 1 to postoperative day 5
Cardiopulmonary Bypass Duration
The correlation between the time from the start to the end of cardiopulmonary bypass and pressure injury was investigated, and the total time of cardiopulmonary bypass (in minutes) was measured.
Time frame: During surgery
CPB Temperature at Termination
To investigate the correlation between core temperature (°C) at the termination of cardiopulmonary bypass and pressure injury.
Time frame: At the time of cardiopulmonary bypass termination during surgery
Lowest Cardiopulmonary Bypass Temperature
To investigate the correlation between the temperature at which the body is cooled to its lowest point during (°C) cardiopulmonary bypass and pressure injury.
Time frame: From initiation to termination of cardiopulmonary bypass during surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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