NCT01048307

Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Randomised, Controlled, Clinical Trial on the Safety and Efficacy of Prontosan Wound Irrigation Solution Compared to Standard Therapy in the Treatment of Hard-to-Heal Venous Leg Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Calvary Hospital, Bronx, NY · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

Conditions

• Wound Care
• Venous Ulcer Care
• Wound Cleansing
• Chronic Wound Care

Interventions

Type	Name	Description
DEVICE	Prontosan wound irrigation solution	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).

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-01-13
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States