Multischiume: Prevention of Pressure Ulcer on the Sacrum

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Completed

CT.gov ID

NCT03900455

Collaborator

(none)

711

Enrollment

Locations

Arms

4.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer Risk	Device: Hydrocellular polyurethane foam multilayer dressing Procedure: Standard preventive care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

711 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Oct 21, 2019

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydrocellular polyurethane foam multilayer dressing	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 Other Names: ALLEVYN LIFE 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
Active Comparator: 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

Arm

Intervention/Treatment

Experimental: Hydrocellular polyurethane foam multilayer dressing

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

Other Names:

ALLEVYN LIFE

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

Active Comparator: standard preventive care

Procedure: Standard preventive care

Outcome Measures

Primary Outcome Measures

Rate of any type of pressure ulcer in the sacral area. [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 Outcome Measures

Pressure Ulcer Rate in the Sacral Area of Category≥ II [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).
Skin irritation/damage due to the adhesive dressing [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.
Number of dressing used per patient. [On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo	Alessandria	Italy	15121
2	Ausl Bologna Ospedale Maggiore	Bologna	Italy	40133
3	Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna	Bologna	Italy	40138
4	Ausl della Romagna	Cesena	Italy	47521
5	Fondazione IRCCS Policlinico San Matteo	Pavia	Italy	27100
6	Azienda USL- IRCCS di Reggio Emilia	Reggio Emilia	Italy	42122
7	Policlinico Universitario Campus Bio-Medico di Roma	Roma	Italy	00128
8	APSS Trento	Trento	Italy	38123
9	Azienda Ospedaliera Universitaria Integrata di Verona	Verona	Italy	37126