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

Venous Leg Ulcer Clinical Trial

Official title:

Pilot, Randomised, Double-blind, Controlled Clinical Trial on the Combined Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel in the Reduction in Size and Change in Bioburden of Hard-to-heal Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153633
• Other study ID #: OPM-G-H 0901
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2010
• Last updated: March 18, 2014
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: March 2014
• Source: B. Braun Ltd. Centre of Excellence Infection Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Prontosan Wound Irrigation Solution and Prontosan Wound Gel
The treatment procedures (after a 1 week run-in) include: Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation 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) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.
• Normal Saline and Placebo Gel
The treatment procedures (after a 1 week run-in) include: Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation 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) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.

Locations

Country	Name	City	State
United Kingdom	Cardiff University, Department of Wound Healing	Cardiff	Wales

Sponsors (1)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change of Wound Size From Baseline to Last Visit		12 Weeks	No
Primary	Healing of Target Ulcer atV6/EOS	Number of ulcers healed at V6/EOS	12 weeks	No
Primary	Absolute Change of Target Ulcer From Baseline to Last Visit		12 weeks	No
Secondary	Number of Different Microganisms at V6/EoS		12 Weeks	No
Secondary	Pain	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'.	12 Weeks	No
Secondary	Condition of Wound Bed	Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS	12 Weeks	No