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Completed

NCT Number: NCT02692482

Polyurethane Foam on the Sacrum for Prevention

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.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydrocellular polyurethane foam multilayer dressing

Device

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

Standard care

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2016
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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