Polyurethane Foam on the Sacrum for Prevention
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 |
---|---|---|
|
N/A |
Study Design
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:
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
- 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
- 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.]
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 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
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.- 22022016
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
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%
|
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%
|
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%
|
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
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 |
cristiana.forni@ior.it |
- 22022016