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Prevention of Pressure Ulcer on the Sacrum

NCT03900455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2021-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Pressure Ulcer Risk

Interventions

DEVICE

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

PROCEDURE

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

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2020-03-12
Completion
2020-03-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900455 on ClinicalTrials.gov