Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06790277

Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention During Cardiac Surgery in the Operating Room

Led by King Abdullah Medical City · Updated on 2025-01-24

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two types of dressings to prevent pressure ulcers in patients undergoing cardiac surgery at King Abdullah Medical City's cardiac center. This randomized control clinical trial compares polyurethane foam (Pink Pad) and Mepilex Border Sacrum dressings to see which is more effective during surgical procedures, especially in patients positioned in the Trendelenburg position. Both dressings are used alongside standard pressure ulcer prevention care based on international guidelines and risk assessments using the Braden Scale at hospital admission. Patients receive one of the two dressings during surgery in the operating room. The polyurethane foam system includes a pink foam pad, lift sheet, body straps, head rests, and boot liners, while the Mepilex dressing is a multilayer foam designed for the sacrum area. After surgery, patients are examined by the head nurse of the wound management team immediately, and then again on day 3 and day 7 post-operation. Dressings are removed after 7 days or earlier if clinically needed. If a patient is discharged before day 7, examination occurs before discharge. Follow-up lasts up to 7 days post-operation for each participant. Participants will be monitored for pressure ulcer development during the 7-day follow-up period. Assessments include clinical examinations by nursing staff to detect any skin changes or pressure ulcers. Patients unable to continue due to death or change in care setting are excluded from continuing. The main outcome measured is the incidence of pressure ulcers within 7 days after surgery. This study aims to provide evidence on which dressing better supports pressure ulcer prevention in cardiac surgery patients.

CONDITIONS

Official Title

Polyurethane Foam-Pink Pad (RCT) Use in OR

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects 18 years or older
  • Willing to participate in the study
  • Patients undergoing cardiac surgery
  • Patients at risk for pressure ulcer development as measured by the Braden Scale
  • Patients with intact skin and a life expectancy greater than 72 hours based on clinical judgment
Not Eligible

You will not qualify if you...

  • Subjects younger than 18 years
  • Not consenting to participate in the study
  • Patients with suspected hypersensitivity to any ingredients in the dressings
  • Patients unable to continue the study due to death or change in care setting

AI-Screening

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Trial Site Locations

Total: 1 location

1

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, Saudi Arabia, 21955

Actively Recruiting

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Research Team

W

Wedian O. Almowallad / Head of Clinical Trial Department, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effectiveness of a Single-Use Polyurethane Foam Positioning Pad Compared With Five-Layer Foam Sacral Dressing for Pressure Ulcer Prevention in the Operating Room: A Randomized Controlled Clinical Trial.

Ebtisam Abdellatif Elhihi, Samah Ali Almuwallad, Bayan Mansour Alqrashi...

https://pubmed.ncbi.nlm.nih.gov/40791282