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

NCT01153633 | Completed Phase 4 Results

• 1 other identifier: OPM-G-H 0901
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (3)

• Percent Change of Wound Size From Baseline to Last Visit

  12 Weeks

• Healing of Target Ulcer atV6/EOS

  Number of ulcers healed at V6/EOS

  12 weeks

• Absolute Change of Target Ulcer From Baseline to Last Visit

  12 weeks

Secondary Outcomes (3)

• Number of Different Microganisms at V6/EoS

  12 Weeks

• Pain

  12 Weeks

• Condition of Wound Bed

  12 Weeks

Study Arms (2)

Prontosan Wound Solution and Gel

ACTIVE COMPARATOR

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)

Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

Normal Saline and Placebo Gel

PLACEBO COMPARATOR

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)

Device: Normal Saline and Placebo Gel

Interventions

Prontosan Wound Irrigation Solution and Prontosan Wound Gel DEVICE

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.

Prontosan Wound Solution and Gel

Normal Saline and Placebo Gel DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Study Sites (1)

Cardiff University, Department of Wound Healing

Cardiff, Wales, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Most likely the non-statistical significant results are due to the small sample size. No sample size calculation and statistical analysis was planned a priori because it was a pilot study.

Results Point of Contact

• Title: Medical Scientific Affairs Manager
• Organization: B. Braun Medical AG

+41 58 258 55 47

Study Officials

• Keith Harding, MD

  Cardiff University, Department of Wound Healing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-03

Locations

GB (1)