Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Sponsor

Calvary Hospital, Bronx, NY (Other)

Overall Status

Completed

CT.gov ID

NCT01048307

Collaborator

B. Braun Medical SA (Industry)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wound Care Venous Ulcer Care Wound Cleansing Chronic Wound Care	Device: Prontosan wound irrigation solution	N/A

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:

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).

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:

reduction of slough and necrotic tissue
control of exudate
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:

adverse drug reaction
adverse events
early withdrawal from the study

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prontosan wound irrigation solution 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 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). Other Names: Wound irrigation solution containing PHMB Polihexanide Betaine Wound cleanser
Placebo Comparator: Saline irrigation (standard care control) 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). Other Names: Wound irrigation solution containing PHMB Polihexanide Betaine Wound cleanser

Arm

Intervention/Treatment

Experimental: Prontosan wound irrigation solution

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

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).

Other Names:

Wound irrigation solution containing PHMB

Polihexanide

Betaine

Wound cleanser

Placebo Comparator: Saline irrigation (standard care control)

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

Other Names:

Wound irrigation solution containing PHMB

Polihexanide

Betaine

Wound cleanser

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Adverse device effect (s) Adverse events [volunteered at any time or during weekly evaluation visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)