Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers

Study Overview
=================
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®.

Official Title
-----------------
Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers: An Open, Controlled, Randomized Study, With Blinded Endpoint (PROBE Trial): CUCO-UV Study

Conditions
-----------------
Venous Leg Ulcer, Bacterial Infections, Chronic Ulcer of Skin of Lower Limb Nos

Intervention / Treatment
-----------------
* Combination Product: CUTIMED
* Other: AQUACEL silver


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Severe pain during dressing change Perilesional edema. Local edema. Unpleasant smell. Abundant pus 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CUTIMED<br>After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply the CUTIMED dressing. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. If the wound exudate decreases, or the removal of the dressing is difficult, it will be changed to CUTIMED gel; in case of abundant exudate, the use of alginate without silver will be allowed for the treatment, because it is neutral with the bacterial load, placed on the CUTIMED dressing. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). | Combination Product: CUTIMED<br>* Hydrophobic Dressing<br>|
| Active Comparator: AQUACEL silver<br>After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply Aquacel-Ag. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). | Other: AQUACEL silver<br>* Silver Dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microorganisms' Colonization Level | 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. | Change from baseline, at 4, 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to the wound | Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10. | Change from baseline at 4, 8 and 12 weeks | 
| Wound size (wound reduction percentage) | It will be evaluated by planimetry with PictZar 7.5 software | Baseline, 4, 8 and 12 weeks | 
| Healing time | This outcome will be measure by number of days until healing | Change from baseline at 4, 8 and 12 weeks | 
| Complete wound healing (Resvech 2.0 score) | Complete healing will be considered with a 0 score in the fourth dimension of the Resvech 2.0 scale | Change from baseline at 4, 8 and 12 weeks | 
| Patient quality of life | 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. | Change from baseline at 12 weeks | 
| Adverse Events | Adverse events related with the treatment, referred by patients, caregivers or health professionals | Change from baseline at 4, 8 and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Ulcer, Leg Injuries, Bacterial Infections