Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

NCT ID: NCT01048307

Last Updated: 2010-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-07-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Prontosan wound irrigation solution

Intervention Type: DEVICE

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).

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).

Group Type: PLACEBO_COMPARATOR

Prontosan wound irrigation solution

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Wound irrigation solution containing PHMB; Polihexanide; Betaine; Wound cleanser

Eligibility 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Medical SA

INDUSTRY

Sponsor Role: collaborator

Calvary Hospital, Bronx, NY

OTHER

Sponsor Role: lead

Responsible Party

B. Braun Medical Inc

Principal Investigators

Oscar M Alvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Calvary Hospital, Wound Care

Martin Wendelken, RN, DPM

Role: STUDY_DIRECTOR

Calvary Hospital, Wound Care

Locations

Calvary hospital center for curative and palliative wound care

The Bronx, New York, United States

Countries

United States

Other Identifiers

OPM-I-H-0902

Identifier Type: -

Identifier Source: org_study_id