Chronic Wound Care, Venous Ulcer Care, Wound Care, Wound Cleansing
Conditions
Keywords
prontosan, wound cleansing, wound irrigation, phmb, polihexanide, betaine
Brief 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
Interventions
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).
Sponsors
B. Braun Medical SA
Calvary Hospital, Bronx, NY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score) | weekly |
Secondary
| Measure | Time frame |
|---|---|
| Adverse device effect (s) Adverse events | volunteered at any time or during weekly evaluation visits |
Countries
United States
Outcome results
None listed