To compare the polyurethane foam dressing (hydrocellular) and the hydrocolloid dressing in patients with Pressure Ulcers (stage II) in primary care
| ISRCTN | ISRCTN57842461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57842461 |
| EudraCT/CTIS number | 2012-003945-14 |
| Secondary identifying numbers | PI11-01674 |
- Submission date
- 19/06/2012
- Registration date
- 19/07/2012
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Pressure ulcers are wounds in the skin and underlying tissues that are caused by continuous pressure or friction between an external surface and a bone or cartilage surface. They can lead to complications such as infections, reduce the patient's quality of life and are estimated to cost 5% of the annual health expenses in Spain. Specially designed dressings and bandages can be used to protect pressure ulcers and speed up the healing process. The aim of this study is to assess the effectiveness of two dressings, a polyurethane foam dressing and a hydrocolloid dressing, for the treatment of pressure ulcers.
Who can participate?
Patients aged 18 and over with at least one pressure ulcer
What does the study involve?
Participants are randomly allocated to be treated with either a polyurethane foam dressing or a hydrocolloid dressing. All participants also receive the standard healing procedures and prevention activities, such as regularly changing their position and using pressure-relieving support surfaces such as mattresses and cushions. Healing of the pressure ulcer is assessed by measuring the wound size after 8 weeks. The cost-effectiveness, side effects and convenience of using the dressings are also assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Primary Health Service of the Balearic Islands (Spain)
When is the study starting and how long is it expected to run for?
September 2012 to September 2015
Who is funding the study?
Directorate General for Evaluation and Research Promotion, Carlos III Institute of Health (Spain)
Who is the main contact?
Mrs Angélica Miguélez
amiguelez@ibsalut.caib.es
Contact information
Scientific
C/Terral 37B
S'Arenal-Palma de Mallorca (Illes Balears)
07600
Spain
| Phone | +34 (0)971 442 754 |
|---|---|
| amiguelez@ibsalut.caib.es |
Study information
| Study design | Multicenter open-label randomized clinical trial of two parallel treatment arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | Ethical Committee of the Balearic Islands (Mallorca-Illes Balears) |
| Condition | Stage II pressure ulcer (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/nursing home) 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 addition, 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 with a "patient's diary" where they should note down how often they change position or if they use pressure-relieving surfaces. The position changes are based on the local Good Clinical Practice Guideline elaborated by the Advisory Panel of Pressure Ulcers from Mallorca. This process also has been standardized to reduce bias. If patient is admitted in a home-nursing, leader nurse should note down all this information on nursing records. |
| Intervention type | Other |
| Primary outcome measure | 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 one 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 and time spent in the stage II PrU process of healing. |
| Overall study start date | 30/09/2012 |
| Overall study end date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 820 patients |
| 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 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
Study participating centre
07600
Spain
Sponsor information
Not defined
[Atenció Primària del servei de Salut de les Illes Balears]
C/Reina Esclaraminda 9
Palma (Mallorca-Illes Balears)
07003
Spain
"ROR" |
https://ror.org/00d9y8h06 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/12/2013 | Yes | No |
Editorial Notes
15/10/2020: No publications found.
22/05/2017: Plain English summary added.
