CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 359 enrolled
Drug / intervention
hydrocellular polyurethane foam multilayer dressing +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02692482
NCT02692482N/ACompleted

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.

Istituto Ortopedico Rizzoli·interventional·Posted Feb 26, 2016·Updated Jun 19, 2019

In Brief

A clinical study evaluating hydrocellular polyurethane foam multilayer dressing and standard care for Hip Fracture and Pressure Ulcer. Completed, enrolled 359 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 26, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.3 years ago

Interventions

hydrocellular polyurethane foam multilayer dressingdevice

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

standard careprocedure

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.