Hip Fracture, Pressure Ulcer
Conditions
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.
Interventions
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
PROCEDUREstandard 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.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polyurethane Foam 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 | 177 |
| 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. | 182 |
| Total | 359 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Polyurethane Foam | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 84.3 years STANDARD_DEVIATION 7.7 | 83.2 years STANDARD_DEVIATION 7.7 | 83.7 years STANDARD_DEVIATION 7.7 |
| Braden score | 15.4 units on a scale STANDARD_DEVIATION 2.4 | 15.4 units on a scale STANDARD_DEVIATION 2 | 15.4 units on a scale STANDARD_DEVIATION 2.2 |
| Number of Participants with Neck Fracture | 94 Participants | 94 Participants | 188 Participants |
| Sex: Female, Male Female | 144 Participants | 145 Participants | 289 Participants |
| Sex: Female, Male Male | 33 Participants | 37 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 177 | 2 / 182 |
| other Total, other adverse events | 0 / 177 | 0 / 182 |
| serious Total, serious adverse events | 0 / 177 | 0 / 182 |
Outcome results
Primary
Number of Participants With Pressure Sores
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Number of Participants With Pressure Sores | 8 Participants |
| Standard Care | Number of Participants With Pressure Sores | 28 Participants |
Secondary
Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf) | 7 Participants |
| Standard Care | Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf) | 7 Participants |
Secondary
Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing | 2 Participants |
| Standard Care | Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing | 0 Participants |
Secondary
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification | 6 Participants |
| Standard Care | Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification | 17 Participants |