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Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

This study has been completed.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by:
Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01048307
First received: January 12, 2010
Last updated: August 16, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Wound Care
Venous Ulcer Care
Wound Cleansing
Chronic Wound Care
 Device: Prontosan wound irrigation solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Calvary Hospital, Bronx, NY:

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) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse device effect (s) Adverse events [ Time Frame: volunteered at any time or during weekly evaluation visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Prontosan wound irrigation solution
  • 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:
  • Prontosan wound irrigation solution
  • Wound irrigation solution containing PHMB
  • Polihexanide
  • Betaine
  • Wound cleanser

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
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048307

Locations
United States, New York
Calvary hospital center for curative and palliative wound care
Bronx, New York, United States, 10461
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
B. Braun Medical SA
Investigators
Principal Investigator: Oscar M Alvarez, PhD Calvary Hospital, Wound Care
Study Director: Martin Wendelken, RN, DPM Calvary Hospital, Wound Care
  More Information

No publications provided

Responsible Party: Ali Koca, MD, B. Braun Medical Inc
ClinicalTrials.gov Identifier: NCT01048307     History of Changes
Other Study ID Numbers: OPM-I-H-0902
Study First Received: January 12, 2010
Last Updated: August 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Calvary Hospital, Bronx, NY:
prontosan
wound cleansing
wound irrigation
 phmb
polihexanide
betaine

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
 Betaine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013