Polyurethane Foam-Pink Pad (RCT) Use in OR

Last updated: January 21, 2025
Sponsor: King Abdullah Medical City
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Polyurethane foams (Pink Pad)

Mepilex Border Sacrum dressings

Clinical Study ID

NCT06790277
23-1093
2323
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 asper clinical judgement.

Exclusion

Exclusion Criteria:

  • Subjects under 17

  • Not consenting to participate

  • Patients with suspected hypersensitivity reactions to any of the dressingformulation's ingredients.

  • Patients who are unable to continue the study because of death or change in the caresetting.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Polyurethane foams (Pink Pad)
Phase:
Study Start date:
October 10, 2023
Estimated Completion Date:
October 10, 2025

Study 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,

Connect with a study center

  • King Abdulla Medical City in Holy capital

    Mecca, Western Reagan 21955
    Saudi Arabia

    Active - Recruiting

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