Polyurethane Foam on the Sacrum for Prevention

Not Applicable

Completed

• Conditions: Pressure Ulcer; Hip Fracture
• Interventions: Procedure: standard care; Device: hydrocellular polyurethane foam multilayer dressing

• Registration Number: NCT02692482
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Study Start: 2016-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-08-03
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Results First Posted: 2019-06-19
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard care	-
polyurethane foam	hydrocellular polyurethane foam multilayer dressing	Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area
polyurethane foam	standard care	Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth 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.
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.	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).
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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy