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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier:
NCT01153633
First received: June 28, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Venous Leg Ulcer
Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Device: Normal Saline and Placebo Gel
Phase 4

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

Resource links provided by NLM:


Further study details as provided by B. Braun Ltd. Centre of Excellence Infection Control:

Primary Outcome Measures:
  • Percent Change of Wound Size From Baseline to Last Visit [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Healing of Target Ulcer atV6/EOS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of ulcers healed at V6/EOS

  • Absolute Change of Target Ulcer From Baseline to Last Visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Different Microganisms at V6/EoS [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS


Enrollment: 34
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prontosan Wound Solution and 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)
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.
Placebo Comparator: 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)
Device: 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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153633

Locations
United Kingdom
Cardiff University, Department of Wound Healing
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
B. Braun Ltd. Centre of Excellence Infection Control
Investigators
Principal Investigator: Keith Harding, MD Cardiff University, Department of Wound Healing
  More Information

No publications provided

Responsible Party: B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier: NCT01153633     History of Changes
Other Study ID Numbers: OPM-G-H 0901
Study First Received: June 28, 2010
Results First Received: May 29, 2012
Last Updated: March 18, 2014
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Cardiovascular Diseases
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014