Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06790277

Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Controlled Trial

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

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two types of dressings, polyurethane foam (Pink Pad) and Mepilex Border Sacrum dressings, to prevent pressure ulcers in patients undergoing cardiac surgery at King Abdullah Medical City. The study focuses on patients at risk for pressure ulcers, using standard hospital protocols based on international guidelines to assess risk and provide prevention. This randomized clinical trial aims to evaluate which dressing may better help prevent pressure ulcers during surgery, especially for patients positioned in ways that increase risk, such as the Trendelenburg position. The study involves two intervention groups: one using a single-use polyurethane foam system including a pink foam pad and related supports, and the other using self-adherent multilayer foam dressings applied to the sacrum. Both interventions are applied by operating room nurses during surgery. Patients will be examined by the wound management team after surgery and again at 3 and 7 days post-operation. Dressings are removed after 7 days or earlier if clinically needed. If patients are discharged sooner, they are examined before discharge. Follow-up lasts up to 7 days post-operation. Participants will be monitored through scheduled examinations and assessments by the wound management team to check for pressure ulcer development. The study measures the incidence of pressure ulcers within 7 days after surgery as its primary outcome. Any patient unable to continue due to death or changes in care setting will be excluded. Researchers will use risk assessment scales and clinical evaluations to track outcomes, ensuring patient safety and adherence to hospital protocols throughout the study period.

CONDITIONS

Brief 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
  • Patients undergoing cardiac surgery
  • Patients at risk for pressure ulcer development as measured with Braden scale
  • Patients with intact skin and life expectancy over 72 hours according to clinical judgement
Not Eligible

You will not qualify if you...

  • Subjects under 18 years old
  • Not consenting to participate
  • Patients with suspected hypersensitivity to dressing ingredients
  • Patients unable to continue due to death or change in care setting

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Surgical procedure day

Participants undergo surgery during which either the Polyurethane foam (Pink Pad) or Mepilex Border Sacrum dressing is applied for pressure ulcer prevention.

1 visit (in-person) during surgery

Post-operative Follow-up

Duration - Up to 7 days post-operation

Participants are examined by the wound management team after the operation, then again at day 3 and day 7 post-operation to assess the effectiveness of the dressing and monitor for pressure ulcers.

3 visits (in-person) post-operation: immediately after surgery, day 3, and day 7

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