N/A
N=359
Polyurethane Foam on the Sacrum for Prevention
Hip Fracture · Pressure Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02692482 ↗Enrolled (actual)
359
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Pressure Sores — 8; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hydrocellular polyurethane foam multilayer dressing (Device); standard care (Procedure)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Istituto Ortopedico Rizzoli
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pressure Sores |
8; 28 | — |
| SECONDARY Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf) |
7; 7 | — |
| SECONDARY Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification |
6; 17 | — |
| SECONDARY Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing |
2; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02692482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.