effect of prontosan wound irrigation solution on venous ulcers

Conditions: Wound Care; Venous Ulcer Care; Wound Cleansing; Chronic Wound Care

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

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

Eligibility criteria:
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)

Keywords: prontosan wound cleansing wound irrigation phmb polihexanide betaine