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Completed

NCT Number: NCT03900455

Prevention of Pressure Ulcer on the Sacrum

The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.

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Key information

Conditions

Pressure Ulcer Risk Pressure Ulcer 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

ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients at risk to develop Pressure Ulcer (Braden scale <17)
  • without sacrum Pressure Ulcer
  • Patients or legal guardians who give their consent to take part in the study

Exclusion criteria

  • Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products

Treatment and study plan

hydrocellular polyurethane foam multilayer dressing

Device

Application of a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care

Other names: ALLEVYN LIFE

Standard preventive care

Procedure

Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure

Primary outcomes

  1. Rate of any type of pressure ulcer in the sacral area.

    Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

    The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).

Secondary outcomes

  1. Pressure Ulcer Rate in the Sacral Area of Category≥ II

    Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

    The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).

  2. Skin irritation/damage due to the adhesive dressing

    Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

    Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated.

  3. Number of dressing used per patient.

    Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial

Acronym: Multischiume

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2019
Registry last updated
Feb 17, 2021

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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