Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel

Phase 4

Completed

Conditions: Venous Leg Ulcer

Interventions: Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Device: Normal Saline and Placebo Gel

Registration Number: NCT01153633

Lead Sponsor: B. Braun Ltd. Centre of Excellence Infection Control

Brief Summary: The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.

Detailed Description: SUMMARY

Sponsor: B. BRAUN Medical AG

Trade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel

Active substance: Polihexanide (0.1%) Betaine (0.1%)

Study Duration (per patient):

13 weeks, including the 1 week run in period

Primary Objective:

To evaluate the efficacy of the combination of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the reduction of wound size of hard-to-heal venous leg ulcers compared to control saline irrigation solution and inactive gel.

Secondary Objectives:

To assess the change in bio-burden (assessment of organisms present) and to determine local tolerance as well as reduction in pain and to monitor exudate control.

Methodology:

A pilot randomised, double-blind, controlled clinical trial at a single centre

Planned number of patients:

A sample size of N= 15 evaluable patients was estimated for each treatment group (group "A" and "B"). Adding a dropout rate of approx. 25% results in a total number of patients for both treatment groups of N=38.

Study Visits:

Visit 0 (-1 week) - Screening Visit 1 ( Week 0) - Treatment and assessment visit Visit 2 (Week 1, day 7 +/- 1 day) - Treatment and assessment visit Visit 3 (Week 2, day14 +/- 1 day) - Treatment and assessment visit Visit 4 (Week 4, day 28 +/- 2 days) - Treatment and assessment visit Visit 5 (Week 8, day 56 +/- 2 days) - Treatment and assessment visit Visit 6 (Week 12, day 84 +/- 2 days) - End of study following 12 weeks of treatment or at healing whichever is soonest

The number of additional visits will be recorded in the Case Report Forms.

Treatment efficacy assessment:

Clinical signs and symptoms will be compared between the two randomised groups with microbiological analysis and, computer planimetry assessments of ulcer size, using Visitrak™ (Smith \& Nephew), and digital photography at entry to the study, at each planned study visit and at healing or 12 weeks, whichever is soonest.

Tolerance assessment:

The tolerability of study treatment will be evaluation based on the intensity and the course of adverse events (undesired concomitant effects, both subjectively perceived symptoms and objectively detected signs of disease). Tolerance assessments will take place from visit 2 onwards

Assessment methods:

1. Assessment of clinical signs and symptoms, in particular related to development of infection:

* reduction of slough and necrotic tissue

* control of exudate

* presence of granulation tissue

* reduction of inflammatory signs (surrounding skin)

* pain

2. Ulcer computerised planimetry using Visitrak™

3. Microbiological analysis for bioburden (the bioburden within an ulcer relates to a microbiological qualitative and quantitative assessment of organisms present) assessed by wound swab or biopsy

4. Serial photography with blinded assessment of progress using linear analogue scale

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

Inclusion Criteria

Males and females aged > 18 who are able to give informed consent
Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)
Venous leg ulcer present for ≥4 weeks
Surface area of the target ulcer ≥2cm2 and <100cm2 with the largest length not being >10cm
ABPI ≥ 0.7

Exclusion Criteria

Age below 18 years
Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
Pregnant or breast feeding women
Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics
Involvement in other trials within the past 1 month
Sensitivity to any of the components of Prontosan® or dressing material
Intolerance to compression therapy
Active osteomyelitis in the ulceration area
Active rheumatoid or collagen disease of blood vessels treated with corticosteroids
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
Poorly controlled Diabetes (HBA1C > 12%)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prontosan Wound Solution and Gel	Prontosan Wound Irrigation Solution and Prontosan Wound Gel	Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)
Normal Saline and Placebo Gel	Normal Saline and Placebo Gel	Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)

Primary Outcome Measures

Name	Time	Method
Absolute Change of Target Ulcer From Baseline to Last Visit	12 weeks
Percent Change of Wound Size From Baseline to Last Visit	12 Weeks
Healing of Target Ulcer atV6/EOS	12 weeks	Number of ulcers healed at V6/EOS

Secondary Outcome Measures

Name	Time	Method
Number of Different Microganisms at V6/EoS	12 Weeks
Pain	12 Weeks	Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'.
Condition of Wound Bed	12 Weeks	Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS