NCT02692482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

February 23, 2016

Results QC Date

August 3, 2017

Last Update Submit

March 19, 2019

Conditions

Hip FracturePressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

polyurethane foam

EXPERIMENTAL

Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area

Device: hydrocellular polyurethane foam multilayer dressingProcedure: standard care

standard care

ACTIVE COMPARATOR
Procedure: standard care

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

Also known as: allevyn life
polyurethane foam
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.

polyurethane foamstandard care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Hip FracturesPressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Cristiana Forni
Organization
Istituto Ortopedico Rizzoli
cristiana.forni@ior.it
0516366694

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)