Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

NCT07379294 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(I)-20250378
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CAD - Coronary Artery Disease; CABG; Valve Disease, Heart; Aortic Diseases; Valve Heart Stenosis; Aortic Aneurysm; Mitral Disease; AORTIC VALVE DISEASES; Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (3)

• Cardiopulmonary Bypass Duration

  During surgery

• CPB Temperature at Termination

  At the time of cardiopulmonary bypass termination during surgery

• Lowest Cardiopulmonary Bypass Temperature

  From initiation to termination of cardiopulmonary bypass during surgery

Study Arms (2)

Prophylactic soft foam Dressing

EXPERIMENTAL

In addition to general routine skin protection measures, also add soft foam dressings.

Device: CONVAFoam Hydrofiber Dressing; Other: Standard Pressure Injury Prevention Care

Standard Pressure Injury Prevention Care

ACTIVE COMPARATOR

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

Interventions

CONVAFoam Hydrofiber Dressing DEVICE

Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence)

Also known as: CONVAfoam

Prophylactic soft foam Dressing

Standard Pressure Injury Prevention Care OTHER

Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.

Prophylactic soft foam Dressing; Standard Pressure Injury Prevention Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shih,Wen-Chi: lead

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Aortic Diseases; Aortic Aneurysm; Disease; Aortic Valve Disease; Aortic Dissection

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aneurysm; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-02