Prevention of Pressure Ulcer on the Sacrum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2020-03-19

Brief Summary

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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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Detailed Description

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Conditions

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Pressure Ulcer Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hydrocellular polyurethane foam multilayer dressing

Group Type EXPERIMENTAL

Hydrocellular polyurethane foam multilayer dressing

Intervention Type 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

Standard preventive care

Intervention Type 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

standard preventive care

Group Type ACTIVE_COMPARATOR

Standard preventive care

Intervention Type 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

Interventions

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Hydrocellular polyurethane foam multilayer dressing

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

Intervention Type DEVICE

Standard preventive care

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

Intervention Type PROCEDURE

Other Intervention Names

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ALLEVYN LIFE

Eligibility Criteria

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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