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NCT Number: NCT06790277

Polyurethane Foam-Pink Pad (RCT) Use in OR

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.

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Key information

Conditions

Cardiac Surgery Subjects Pressure Ulcer Pressure Ulcer Prevention Pressure Ulcer of Skin Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, 21955, Saudi Arabia

Location status: Recruiting

Location contact

Ebtisam Abd Elatif Ebrahim

PRINCIPAL_INVESTIGATOR

wedian O Almowallad

CONTACT

[email protected]

: 012 5549999 ext. Ext: 18008

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepilex Border Sacrum dressings

Device

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 operation for each subject. Any patient will be unable to continue the study because of death or change in the care setting will be excluded from the study.

Polyurethane foams (Pink Pad)

Device

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 operation for each subject. Any patient will be unable to continue the study because of death or change in the care setting will be excluded from the study.

Primary outcomes

  1. Pressure ulcer incidence

    Time frame: 7 days

    Pressure ulcer incidence will be assessed by using Bates-Jensen Wound Assessment Tool (BWAT) after operation then day 3 and day 7 for both treatments.

Secondary outcomes

  1. occurrence of pressure ulcer

    Time frame: 7 days

    The occurrence of pressure ulcer will be documented in data collection then calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

012 5549999 ext. Ext: 18008

Sponsors and collaborators

Lead sponsor

King Abdullah Medical City

Other Gov

Registry information

Official study title

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

Acronym: pink-pad

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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