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

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

Study Overview

• Status: Completed
• Conditions: Wound Care; Venous Ulcer Care; Wound Cleansing; Chronic Wound Care
• Intervention / Treatment: Device: Prontosan wound irrigation solution

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Calvary Hospital Center for Curative and Palliative Wound Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Adverse device effect (s) Adverse events	volunteered at any time or during weekly evaluation visits

Collaborators and Investigators

• Sponsor: Calvary Hospital, Bronx, NY
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): August 17, 2010
• Last Update Submitted That Met QC Criteria: August 16, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: betaine; prontosan; wound cleansing; wound irrigation; phmb; polihexanide
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Wounds and Injuries; Varicose Ulcer; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Disinfectants; Lipotropic Agents; Pharmaceutical Solutions; Betaine; Polihexanide
• Other Study ID Numbers: OPM-I-H-0902