Effect of Prontosan Wound Irrigation Solution on Venous Ulcers
Condition: Wound Care; Venous Ulcer Care; Wound Cleansing; Chronic Wound Care
MeSH terms: Varicose Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      Objective:

      To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment
      of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution

      Methodology:

      Randomised, controlled multi-centre, prospective clinical trial

      Planned number of subjects:

      20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in
      control group (wound irrigation with saline)

      Products under investigation:

      Prontosan® Wound Irrigation Solution

      Study Duration:

      3-4 weeks
    

Detailed description: 
      Investigational product, dose and administration:

      Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group)
      will be applied at inclusion and reapplied after dressing changes.

      The treatment scheme is as follows:

        1. Prontosan® Wound Irrigation Solution (experimental group):

             -  cleansing the wound bed at dressing change with Prontosan® Wound Irrigation
                Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be
                placed on the immediate wound in the form of a moist compress and removed after
                approximately 15 minutes;

             -  placing the primary dressing (Profore® WCL): the dressing will be impregnated with
                Prontosan® Wound Irrigation Solution;

             -  fixing the dressing to the wound using multilayered elastic compression bandaging
                (Profore® bandaging system).

        2. Saline (control group):

             -  cleansing the wound bed at dressing change with saline; a sterile gauze dressing
                impregnated with the saline will be placed on the wound in the form of a moist
                compress and removed after approx.15 minutes;

             -  placing the primary dressing (Profore® WCL): the dressing will be impregnated with
                saline;

             -  fixing the dressing to the wound using multilayered elastic compression bandaging
                (Profore® bandaging system).

      Dressings will be changed and the treatment procedure will be repeated in the clinic
      2x/weekly or more. The efficacy of the treatment procedure will be evaluated on the basis of
      a 2 week observation period.

      Treatment efficacy assessment:

        -  Assessment of clinical signs and symptoms at entry to the study and after one and two
           weeks.

        -  Quantitative and qualitative microbiological analysis at entry to the study and after
           two weeks.

        -  Wound planimetry using PictZar® CDM at entry to the study and after two weeks.

      Primary aim:

        -  clinical signs assessed by:

             1. reduction of slough and necrotic tissue

             2. control of exudate

             3. presence of granulation tissue

        -  reduction of inflammatory signs (surrounding skin)

        -  reduction in wound size (assessed by wound planimetry)

        -  reduction of bacterial load (quantitative and qualitative microbiological

      Secondary aim:

      - tolerance and safety assessment:

        1. adverse drug reaction

        2. adverse events

        3. early withdrawal from the study
    

Intervention name(s): Prontosan wound irrigation solution
Intervention type(s): Device
Intervention description(s): Prontosan® Wound Irrigation Solution (experimental group):
• Active ingredients (Polihexanide 0.1%, Betaine 0.1%) cleansing the wound bed at dressing change with Prontosan® Wound
Saline (control group):
cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
Other intervention name(s): Wound irrigation solution containing PHMB; Polihexanide; Betaine; Wound cleanser
Intervention MeSH terms: Polihexanide; Betaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prontosan; wound cleansing; wound irrigation; phmb; polihexanide; betaine