Menu
Recruiting NCT06790277

Polyurethane Foam-Pink Pad (RCT) Use in OR

No phase Interventional Cardiac Surgery Subjects Pressure Ulcer Prevention Pressure Ulcer of Skin Pressure Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mepilex Border Sacrum dressings, Polyurethane foams (Pink Pad).
Who it may be relevant to
Registry conditions: Cardiac Surgery Subjects, Pressure Ulcer Prevention, Pressure Ulcer of Skin, Pressure Ulcer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.

Detailed description

There are two types of intervention available in King Abdullah medical city for operating room pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position.

Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention.

All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines ( European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the Braden Scale at hospital admission,

Interventions

  • Device Mepilex Border Sacrum dressings
    Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post
  • Device Polyurethane foams (Pink Pad)
    Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post

Primary outcome measures

  • Pressure ulcer incidence [Time frame: 7 days]
Secondary outcome measures (1)
  • occurrence of pressure ulcer [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Subjects ≥ 18.
  • Willing to participate.
  • Patients undergoing cardiac surgery.
  • Patient who is at risk for PU development as measured with Braden scale.
  • Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.

Exclusion criteria

  • Subjects under 17
  • Not consenting to participate
  • Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients.
  • Patients who are unable to continue the study because of death or change in the care setting.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Saudi Arabia · 1 center
  • King Abdulla Medical City in Holy capital — Mecca

Publications

  • Elhihi EA, Almuwallad SA, Alqrashi BM, Nada EM, Alduaiji NA, Alfakeeh AA. 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. Health Sci Rep. 2025 Aug 10;8(8):e70963. doi: 10.1002/hsr2.70963. eCollection 2025 Aug. PMID 40791282

Identifiers

NCT: NCT06790277 · 23-1093 · 2323

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗