Chronic Wound Care, Pressure Ulcer, Wound Cleansing
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.
Interventions
DRUGIsotonic solution (saline or lactated ringer)
* cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G) * positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes * dressing with isotonic solution
* cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G) * positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes * dressing with Prontosan Wound Irrigation solution
Sponsors
B. Braun Medical SA
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough * Braden index at baseline\>=10 * Ulcer area\<80 cm2 * Ability to give an informed consent
Exclusion criteria
* Braden index at baseline\<10 * Current therapy with corticosteroids or immunosuppressor or radiotherapy * Sensitivity to any of the components of Prontosan® Solution * Diabetic foot ulcer * Current use of local antiseptics on the wound bed * Previous recruitment of another ulcer in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of necrotic tissue (Pressure Sore Status Tool-PSST) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) |
| Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of wound dressing (clinical score) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) |
Countries
Italy
Outcome results
None listed