Stage 3 or 4 pressure ulcer Skin and Connective Tissue Diseases
Conditions
Interventions
Each patient is treated with Algosteril and followed for a maximum of 8 weeks.
5 protocol visits are planned: Day of inclusion, Week 2, Week 4, Week 6 and Week 8 or Day of cicatrisatio
Sponsors
Brothier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with stage 3 or 4 pressure ulcer 2. Aged 18 years or older
Exclusion criteria
Exclusion criteria: Head pressure ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacity is evaluated by the average relative reduction of the pressure ulcer surface. Surface is measured in cm² at D inclusion, W2, W4, W6 and W8 or D cicatrisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy evaluated by the average relative reduction of the pressure ulcer volume. Volume is measured in cm3 at D inclusion, W2, W4, W6 and W8 or D cicatrisation 2. Wound evolution measured using the amount of exudate estimated using a 4-point scale at each visit 3. Quality of peri-wound estimated at each visit using a 2-point scale 4. Presence or not of clinical signs of infection is described at each visit 5. Tolerance measured using adverse events related to Algosteril | — |
Countries
France
Outcome results
None listed