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

University of Malaga204 enrolled

Overview

This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

204

Conditions

Venous Leg Ulcer Bacterial Infections Chronic Ulcer of Skin of Lower Limb Nos

Interventions

CUTIMEDCOMBINATION_PRODUCT

Hydrophobic Dressing

AQUACEL silverOTHER

Silver Dressing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Málaga

Málaga, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline, at 4, 8 and 12 weeks

Secondary Outcomes

Pain due to the wound

Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10.

Time frame: 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

Time frame: Baseline, 4, 8 and 12 weeks

Healing time

This outcome will be measure by number of days until healing

Time frame: 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

Time frame: 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.

Time frame: Change from baseline at 12 weeks

Adverse Events

Central Contacts

José Miguel Morales Asencio, PhD

CONTACT

0034951952833 jmmasen@uma.es

Juan Carlos Morilla Herrera, PhD

CONTACT

jc.morilla.sspa@juntadeandalucía.es

Data from ClinicalTrials.gov

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