Bacterial Infections, Chronic Ulcer of Skin of Lower Limb Nos, Venous Leg Ulcer
Conditions
Keywords
Venous Ulcer, Leg Injuries, Bacterial Infections
Brief summary
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
Detailed description
Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process. The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments. In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
Interventions
COMBINATION_PRODUCTCUTIMED
Hydrophobic Dressing
OTHERAQUACEL silver
Silver Dressing
Sponsors
BSN Medical GmbH
Andalusian Health Service
University of Malaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five: 1. Severe pain during dressing change 2. Perilesional edema. 3. Local edema. 4. Unpleasant smell. 5. Abundant pus 6. Microbial colonization higher than 100000 CFUs
Exclusion criteria
* Patients younger than 18 years old. * Venous ulcer with signs of infection which requires antibiotic therapy * Venous ulcers that do not meet Lazareth and Moore criteria * Arterial ulcers. * Patients with type I or type II diabetes. * Patients with immunosuppression of any etiology or in immunosuppressive treatment or with NSAIDs. * Patients with rheumatoid arthritis in the acute phase. * Patients with dermatitis prior to the appearance of the ulcer. * Patients with neuropathy or lack of sensitivity of any etiology. * Patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microorganisms' Colonization Level | Change from baseline, at 4, 8 and 12 weeks | Evaluated by Reverse Transcription Polymerase Chain Reaction (RT-PCR) identification technique and quantified in colony forming units (CFU) and in ng of bacterial DNA per μL of vascular ulcer exudate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound size (wound reduction percentage) | Baseline, 4, 8 and 12 weeks | It will be evaluated by planimetry with PictZar 7.5 software |
| Healing time | Change from baseline at 4, 8 and 12 weeks | This outcome will be measure by number of days until healing |
| Complete wound healing (Resvech 2.0 score) | Change from baseline at 4, 8 and 12 weeks | Complete healing will be considered with a 0 score in the fourth dimension of the Resvech 2.0 scale |
| Patient quality of life | Change from baseline at 12 weeks | Measured with Charing Cross Venous Ulcer Questionnaire (CCVUQ), in its Spanish version. The CCVUQ is composed of 22 items that determine four important dimensions for health: the social function, domestic activities, the aesthetic dimension and the emotional state. Each item should be assessed using a Likert scale with a punctuation from 1 to 5. In their interpretation, lower scores indicate a better quality of life. |
| Adverse Events | Change from baseline at 4, 8 and 12 weeks | Adverse events related with the treatment, referred by patients, caregivers or health professionals |
| Pain due to the wound | Change from baseline at 4, 8 and 12 weeks | Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wound healing evolution | Baseline, 4, 8 and 12 weeks | Measured with Resultados esperados de la valoración y evolución de la cicatrización de las heridas crónicas (Expected results of chronic wound healing assessment and evolution), RESVECH 2.0 scale. The punctuation varies forn 0 to 35, with 6 subscales: Wound size, Depth/affected tissues, Borders, Type of tissue in the wound bed, Type of exudate and Infection/inflammation |
Countries
Spain
Contacts
Primary ContactJosé Miguel Morales Asencio, PhD
Backup ContactJuan Carlos Morilla Herrera, PhD
Outcome results
None listed