An interventional study of Prontosan wound irrigation solution in Wound Care, Venous Ulcer Care and Wound Cleansing, sponsored by Calvary Hospital, Bronx, NY. Completed at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2010-08-17.
Sponsored by Calvary Hospital, Bronx, NY · Not applicable, Interventional, and Treatment
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:
Prontosan® Wound Irrigation Solution (experimental group):
Saline (control group):
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:
Primary aim:
clinical signs assessed by:
Secondary aim:
- tolerance and safety assessment:
Calvary Hospital, Bronx, NY is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
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 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 Prontosan® Wound Irrigation Solution; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore®bandaging system).
Device: Prontosan wound irrigation solution
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).
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).
Also known as: Wound irrigation solution containing PHMB, Polihexanide, Betaine, Wound cleanser
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)
Time frame: weekly
Adverse device effect (s) Adverse events
Time frame: volunteered at any time or during weekly evaluation visits
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Calvary Hospital, Bronx, NY