Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CABG; Valve Disease, Heart; Aortic Aneurysm; Aortic Diseases; Aortic Dissection; Mitral Disease; AORTIC VALVE DISEASES; Valve Heart Stenosis; CAD - Coronary Artery Disease
• Intervention / Treatment: Device: CONVAFoam Hydrofiber Dressing; Other: Standard Pressure Injury Prevention Care

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)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic soft foam Dressing; In addition to general routine skin protection measures, also add soft foam dressings.	Device: CONVAFoam Hydrofiber Dressing; Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence); Other Names: CONVAfoam; Other: Standard 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.
Active Comparator: 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; Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From preoperative baseline (before surgery) to postoperative day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to development of pressure injury	The time (in days) from surgery completion to the first documented occurrence of a pressure injury.	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.	Postoperative day 1 to postoperative day 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During surgery
CPB Temperature at Termination	To investigate the correlation between core temperature (°C) at the termination of cardiopulmonary bypass and pressure injury.	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.	From initiation to termination of cardiopulmonary bypass during surgery

Collaborators and Investigators

• Sponsor: Shih,Wen-Chi

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Aneurysm; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Disease; Coronary Artery Disease; Aortic Aneurysm; Aortic Dissection; Heart Valve Diseases; Aortic Diseases; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: KMUHIRB-F(I)-20250378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No