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

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

Inclusion Criteria:

• males and females aged at least 18 with wounds of venous aetiology (documented by targeted exams) located in the lower limbs
• Ankle Brachial Index (ABI) ≥ 0.7
• patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic) over the 30 days before joining the study

Exclusion Criteria:

Exclusion criteria

• age below 18 years
• presence of clinical infection, or current use of antiseptics or antibiotics
• chronic wounds of long duration (>30cm2 and >1 year duration)
• involvement in other wound related trials within the past 30 days
• sensitivity to any of the components of Prontosan® or dressing material
• intolerance to compression therapy
• active osteomyelitis in the ulceration area
• active rheumatoid arthritis (RA) requiring any immunosuppressive therapy
• collagen vascular disease active treated with steroids
• chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
• plasma protein below 4 g/dl
• anaemia: haemoglobin below 10 g/dl
• both, controlled and uncontrolled diabetics (type 1 or 2)
• patients on any rheological agents (not including aspirin)