Track topics on Twitter Track topics that are important to you
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.
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):
14 weeks, including the 2 week run in period
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.
To assess the change in bio-burden (assessment of organisms present) and to determine local tolerance as well as reduction in pain and smell and to monitor exudate control.
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.
Visit 0 (-2 weeks) - 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 CRF.
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.
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
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)
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
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Venous Leg Uler
Prontosan Wound Irrigation Solution and Prontosan Wound Gel, Normal Saline and Placebo Gel
Cardiff University, Department of Wound Healing
B. Braun Ltd. Centre of Excellence Infection Control
Published on BioPortfolio: 2014-07-24T14:00:50-0400
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 solutio...
This study evaluates the use of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of chronic leg wounds in adults. All participants will use Prontosan and re...
To answer the question: "Do Prontosan instillations decrease time to wound and fracture healing and decrease bacterial load compared to wound vac treatment without Prontosan?," we will enr...
to evaluate the effect of subcutaneous irrigation on wound complications
More patients with diabetes mellitus have led to increasing rates of chronic non-healing wounds. These wounds are colonised with pathogens, including multi-drug resistant organisms. Despit...
To assess the effectiveness of subcutaneous saline irrigation in preventing wound complications after cesarean sections.
Despite overall advances in burn therapy, wound infection remains one of the leading causes of morbidity and mortality in patients with severe burn injuries. This prospective, multicenter, non-compara...
The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap ve...
To examine the correlation between mean arterial pressure (MAP) and wound healing indices and describe an analytical process that can be used accurately and prospectively when evaluating all types of ...
Different types of multidisciplinary concepts for treating non-healing wounds have been developed. However, there is insufficient evidence on the quality of multidisciplinary wound centres, and a limi...
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.
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...