Polyurethane Foam-Pink Pad (RCT) Use in OR

Not Applicable

Recruiting

• Conditions: Cardiac Surgery Subjects; Pressure Ulcer Prevention; Pressure Ulcer of Skin; Pressure Ulcer

• Registration Number: NCT06790277
• Lead Sponsor: King Abdullah Medical City

Brief Summary

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,

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2024-11-25
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-10-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pressure ulcer incidence	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 Outcome Measures

Name	Time	Method
occurrence of pressure ulcer	7 days	The occurrence of pressure ulcer will be documented in data collection then calculated.

Trial Locations

Locations (1)

King Abdulla Medical City in Holy capital; 🇸🇦 Mecca, Western Reagan, Saudi Arabia