Condition category
Skin and Connective Tissue Diseases
Date applied
19/06/2012
Date assigned
19/07/2012
Last edited
08/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Angélica Miguélez

ORCID ID

Contact details

C/Terral 37B
S'Arenal-Palma de Mallorca (Illes Balears)
07600
Spain
+34 971 442 754
amiguelez@ibsalut.caib.es

Additional identifiers

EudraCT number

2012-003945-14

ClinicalTrials.gov number

Protocol/serial number

PI11-01674

Study information

Scientific title

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

Acronym

PrU-II

Study hypothesis

The proportion of stage II ulcers healed after 8 weeks through hydrocellular dressings is not higher than the 10% of the proportion of ulcers healed through hydrocolloid dressings.

Ethics approval

Ethical Committee of the Balearic Islands (Mallorca-Illes Balears)

Study design

Multicenter open label randomized clinical trial of two parallel treatment arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

The main outcome of study is stage II PrU healing (ulcer with epithelialisation tissue).

Intervention

Patients will be randomized using a unic randomisation list obtained by an informatic programme. Each participant center (Primary Health center/ Home nursings) will be provided from this list.

Treatment 1: polyuretane foam dressing
Treatment 2: hydrocolloid dressing

Each patient has the same probability in being cured by polyurethane foam dressing or hydrocolloid one. In addittion, an Investigator's Brochure will explain how to proceed to cure ulcer in order to standardize the process and reduce bias.

If patient is attended at home, he or she or their relatives will be provided of a "patient's diary" where they should note down how often they make positional changings or if they use pressure-relieving surfaces. The positional changings are based on the local Good Clinical Pactice Guideline elaborated by the Advisory Panel of Pressure Ulcers from Mallorca. This process also has been standadized to reduce bias.

If patient is admitted in a home-nursing, leader nurse should note down all this information on nusing records.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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).

Secondary outcome measures

1. Cost-efficacy outcomes:The costs in the proportion of healed ulcers and the costs per treated patient would be calculated to estimate the cost-effectiveness. In order to do this estimation, information relating to direct costs would be collected, implying number of used dressings, frequency in the changing of dressings, use of secondary dressings and time spent in the healing process. Furthermore, the costs due to the evolution of stage II PrU into a higher level, infection or necrosis, days of hospitalisation, additional treatment and treatment of adverse events or complications would also be taken into account. Indirect costs would not be considered.
2. Assessment of safety aspects Outcomes related to the detection of adverse events, complications in the ulcer and infection.
3. Assessment of convenience of dressings of study. Information relating to the following outcomes and regarding the person who is involved in the process of healing and the ones who is receiving it (treatment of the PrU): adherence, management of the dressing, (ease of removal of the dressing), comfort of the patient, pain of the patient during process of healing of stage II PrU anf time spent in the stage II PrU process of healing.

Overall trial start date

30/09/2012

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The sample size was calculated and in total we expect to recruit a total of 820 patients.

Participant 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

Recruitment start date

30/09/2012

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Spain

Trial participating centre

C/Terral 37B
S'Arenal-Palma de Mallorca (Illes Balears)
07600
Spain

Sponsor information

Organisation

Primary Health Service of the Balearic Islands (Spain)

Sponsor details

[Atenció Primària del servei de Salut de les Illes Balears]
C/Reina Esclaraminda 9
Palma (Mallorca-Illes Balears)
07003
Spain

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Directorate General for Evaluation and Research Promotion, Carlos III Institute of Health (Spain) ref: PI11/01674

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Guillén-Solà M, Soler Mieras A, Tomàs-Vidal AM, , A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes., BMC Fam Pract, 2013, 14, 196, doi: 10.1186/1471-2296-14-196.

Additional files

Editorial Notes