Polyurethane Foam on the Sacrum for Prevention

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT02692482
Collaborator
(none)
359
1
2
9
39.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: hydrocellular polyurethane foam multilayer dressing
  • Procedure: standard care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
359 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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.
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: polyurethane foam

Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area

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
Other Names:
  • allevyn life
  • 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.

    Active Comparator: 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.

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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.]

    2. 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).

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Ortopedico Rizzoli Bologna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT02692482
    Other Study ID Numbers:
    • 22022016
    First Posted:
    Feb 26, 2016
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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.
    Period Title: Overall Study
    STARTED 177 182
    COMPLETED 174 178
    NOT COMPLETED 3 4

    Baseline Characteristics

    Arm/Group Title Polyurethane Foam Standard Care Total
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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. Total of all reporting groups
    Overall Participants 177 182 359
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    84.3
    (7.7)
    83.2
    (7.7)
    83.7
    (7.7)
    Sex: Female, Male (Count of Participants)
    Female
    144
    81.4%
    145
    79.7%
    289
    80.5%
    Male
    33
    18.6%
    37
    20.3%
    70
    19.5%
    Number of Participants with Neck Fracture (Count of Participants)
    Count of Participants [Participants]
    94
    53.1%
    94
    51.6%
    188
    52.4%
    Braden score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    15.4
    (2.4)
    15.4
    (2.0)
    15.4
    (2.2)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Pressure Sores
    Description
    Time Frame On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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.
    Measure Participants 177 182
    Count of Participants [Participants]
    8
    4.5%
    28
    15.4%
    2. Secondary Outcome
    Title Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
    Description
    Time Frame On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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.
    Measure Participants 177 182
    Count of Participants [Participants]
    7
    4%
    7
    3.8%
    3. Secondary Outcome
    Title Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification
    Description 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).
    Time Frame On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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. 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.
    Measure Participants 177 182
    Count of Participants [Participants]
    6
    3.4%
    17
    9.3%
    4. Secondary Outcome
    Title Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing
    Description 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.
    Time Frame On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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. 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.
    Measure Participants 177 182
    Count of Participants [Participants]
    2
    1.1%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Polyurethane Foam Standard Care
    Arm/Group Description Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area 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 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. 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.
    All Cause Mortality
    Polyurethane Foam Standard Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/177 (1.1%) 2/182 (1.1%)
    Serious Adverse Events
    Polyurethane Foam Standard Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/177 (0%) 0/182 (0%)
    Other (Not Including Serious) Adverse Events
    Polyurethane Foam Standard Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/177 (0%) 0/182 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Cristiana Forni
    Organization Istituto Ortopedico Rizzoli
    Phone 0516366694 ext 0039
    Email cristiana.forni@ior.it
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT02692482
    Other Study ID Numbers:
    • 22022016
    First Posted:
    Feb 26, 2016
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Mar 1, 2019