To compare the polyurethane foam dressing (hydrocellular) and the hydrocolloid dressing in patients with Pressure Ulcers (stage II) in primary care

Not Applicable

Completed

• Conditions: Stage II pressure ulcer (ulcer with epithelialisation tissue); Skin and Connective Tissue Diseases; Stage II decubitus ulcer and pressure area

• Registration Number: ISRCTN57842461
• Lead Sponsor: Primary Health Service of the Balearic Islands (Spain)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24359122

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-19
• Study Completion: 2015-09-30
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage II PrU healing (ulcer with epithelialisation tissue). Wound size in cm2, exudate and type of tissue through the Pressure Ulcer Healing Chart (PUSH) assessment tool. This information would be weekly collected until the end of the study or until healing of stage II PrU. Moreover, PrU would be stratified depending on the classification established by the European Ulcer Advisory Panel (EPUAP).