Polyurethane Foam-Pink Pad (RCT) Use in OR

NCT06790277 | Recruiting

• 2 other identifiers: 23-10932323
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery Subjects; Pressure Ulcer Prevention; Pressure Ulcer of Skin; Pressure Ulcer

Keywords

five layers sacral foam dressing; PINK PAD; pressure ulcers; Patients undergoing cardiac surgery; Mepilex dressing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• occurrence of pressure ulcer

  7 days

Study Arms (2)

Polyurethane foams (Pink Pad)

ACTIVE COMPARATOR

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)

Mepilex Border Sacrum dressings

ACTIVE COMPARATOR

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

Interventions

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.

Mepilex Border Sacrum dressings

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.

Polyurethane foams (Pink Pad)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah Medical City: lead

Study Sites (1)

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, 21955, Saudi Arabia

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

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

CONTACT

012 5549999; Almwlld.W@kamc.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Research and Evidence Based Practice Department

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: January 24, 2025
• Study Start: October 10, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)