Efficacy of Prontosan Solution on Chronic Ulcers

Study Overview
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Brief Summary
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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.

Conditions
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Pressure Ulcer, Chronic Wound Care, Wound Cleansing

Intervention / Treatment
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* Device: Prontosan wound irrigation solution
* Drug: Isotonic solution (saline or lactated ringer)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prontosan wound irrigation solution<br> | Device: Prontosan wound irrigation solution<br>* 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<br>|
| Active Comparator: Standard care<br> | Drug: Isotonic solution (saline or lactated ringer)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |