Polyurethane Foam-Pink Pad (RCT) Use in OR (pink-pad)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcer; Pressure Ulcer of Skin; Pressure Ulcer Prevention; Cardiac Surgery Subjects
• Intervention / Treatment: Device: Polyurethane foams (Pink Pad); Device: Mepilex Border Sacrum dressings

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wedian O. Almowallad / Head of Clinical Trial Department, Master; Phone Number: Ext: 18008 012 5549999; Email: Almwlld.W@kamc.med.sa

Study Locations

• Saudi Arabia
  • Western Reagan
    • Mecca, Western Reagan, Saudi Arabia, 21955
      • Recruiting
      • King Abdulla Medical City in Holy capital
      • Contact: wedian O Almowallad; Phone Number: Ext: 18008 : 012 5549999; Email: Almwlld.W@kamc.med.sa
      • Principal Investigator: Ebtisam Abd Elatif Ebrahim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polyurethane foams (Pink Pad); a single use system for use in surgical procedures.it will be used only by operating room nurses Patient will be examined by wound management team after the operation then at day 3- and 7-days post operation.	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 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.
Active Comparator: Mepilex Border Sacrum dressings; a single use system for use in surgical procedures.it will be used only by operating room nurses Patient will be examined by wound management team after the operation then at day 3- and 7-days post operation.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure ulcer incidence	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of pressure ulcer	The occurrence of pressure ulcer will be documented in data collection then calculated.	7 days

Collaborators and Investigators

• Sponsor: King Abdullah Medical City

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): October 10, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Patients undergoing cardiac surgery; pressure ulcers; five layers sacral foam dressing; PINK PAD; Mepilex dressing
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 23-1093; 2323 (Other Identifier: SFDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) will not be shared , but the data can be reviewed by regulatory officer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No