A multicenter, randomized, single-blind clinical trial to compare the polyurethane foam dressing (hydrocellular) and the hydrocolloid dressing in patients with Pressure Ulcers (stage II) in primary care

Primary Health Service of the Balearic Islands (Spain)0 sites820 target enrollmentJuly 19, 2012

Overview

Registry

who.int

Start Date

July 19, 2012

End Date

September 30, 2015

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Primary Health Service of the Balearic Islands (Spain)

•1\. Patients \= 18 years old with pressure ulcers (PrU) at stage II diagnostic (\*In the case that a patient has more than one stage II PrU, only the ulcer with the largest surface area would be taken into account. This decision does not imply the stopping of normal treatment for the rest of the ulcers, and neither does stop the prevention of the pressure)
•2\. Patients attended in Primary Care in domiciliary care with stage II PrU
•3\. Patients in nursery homes with stage II PrU

•1\. Patients with a diagnostic of PrU I, III or IV
•2\. Patients with non classifiable PrU
•3\. Hospitalised patients with any stage PrU (including stage II ones)
•4\. Patients with previous surgical treatment of the PrU and/or patients with previously irradiated PrU areas
•5\. Patients who have taken part in another clinical research study in the previous 3 months
•6\. Patients with allergy or hypersensitivity to the materials of the dressings
•7\. Patients with PrU who show signs of basal infection (sepsis/bacterial), cellulitis or osteomyelitis
•8\. Patients with venous ulcers and/or diabetic foot.
•9\. Patients in extreme gravity and/or terminal situation with \< 3 points in the Braden Scale and/or a life expectancy of less than 1 month
•10\. Type I diabetic patients