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

Patients Undergoing Cardiac Surgery Under General Anesthesia (e.g., AVR, MVR, DVR, CABG, Type A Repair, Bentall Procedure, Heart Transplantation); Expected Surgical Duration > 4 Hours; Age ≥ 18 Years; Use of Cardiopulmonary Bypass (CPB) During Surgery; Intact Skin Preoperatively, With no Existing Pressure Injuries

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)

• Association between intraoperative temperature maintenance and pressure injury occurrence

  During surgery through postoperative day 5

• Association between cardiopulmonary bypass duration and pressure injury occurrence

  During surgery through postoperative day 5

• Association between cardiopulmonary bypass temperature and pressure injury occurrence

  During surgery through postoperative day 5

Study Arms (2)

Experimental Group

EXPERIMENTAL

AQUACEL Foam Hydrofiber Dressing

Other: Intervention group

Control Group

OTHER

Standard pressure injury prevention care

Other: Control group

Interventions

Intervention group OTHER

routine prevention + foam dressing applied to high-risk pressure areas (heels, sacrococcygeal area, hallux prominence

Also known as: AQUACEL Foam Hydrofiber Dressing

Experimental Group

Control group OTHER

routine measures only (pressure-relieving pad, heel pad, towel/cotton separation, etc.)

Also known as: Standard pressure injury prevention care

Control Group

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

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: February 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01