Stage II pressure ulcer (ulcer with epithelialisation tissue) Skin and Connective Tissue Diseases Stage II decubitus ulcer and pressure area
Conditions
Interventions
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.
Sponsors
Primary Health Service of the Balearic Islands (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Outcome results
None listed