Polyurethane Foam on the Sacrum for Prevention

Pressure Ulcer Clinical Trial

Official title:

Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692482
• Other study ID #: 22022016
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade = II PU

• 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

• Patients with peri-prosthetic or pathological fractures

• Patients with diaphyseal or distal femoral fractures

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures
• Pressure Ulcer

Intervention

Device:
• hydrocellular polyurethane foam multilayer dressing
Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care

Procedure:
• standard care
Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pressure Sores		On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Secondary	Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)		On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Secondary	Pressure Ulcer Rate in the Sacral Area of Grade = II 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).	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Secondary	Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing	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.	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.