Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Calvary Hospital, Bronx, NY20 enrolled

Overview

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

Interventions

Prontosan wound irrigation solutionDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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)

Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes