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Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

2014-07-23 21:11:08 | BioPortfolio

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

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Wound Care

Intervention

Prontosan wound irrigation solution

Location

Calvary hospital center for curative and palliative wound care
Bronx
New York
United States
10461

Status

Recruiting

Source

Calvary Hospital, Bronx, NY

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:08-0400

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Medical and Biotech [MESH] Definitions

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

The washing of a body cavity or surface by flowing solution which is inserted and then removed. Any drug in the irrigation solution may be absorbed.

Removal of degenerated and necrotic epithelium and underlying connective tissue of a periodontal pocket in an effort to convert a chronic ulcerated wound to an acute surgical wound, thereby insuring wound healing and attachment or epithelial adhesion, and shrinkage of the marginal gingiva. The term is sometimes used in connection with smoothing of a root surface or ROOT PLANING. (Jablonski; Illustrated Dictionary of Dentistry, 1982)

Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

The washing of the VAGINA cavity or surface with a solution. Agents or drugs can be added to the irrigation solution.

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