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Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers (CUCO-UV)

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ClinicalTrials.gov Identifier: NCT03667937
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
BSN Medical GmbH
Andalusian Health Service
Information provided by (Responsible Party):
JOSE MIGUEL MORALES ASENCIO, University of Malaga

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

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Bacterial Infections Chronic Ulcer of Skin of Lower Limb Nos Combination Product: CUTIMED Other: AQUACEL silver Phase 4

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®.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CUTIMED

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
Hydrophobic Dressing

Active Comparator: AQUACEL silver

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
Silver Dressing




Primary Outcome Measures :
  1. Microorganisms' Colonization Level [ Time Frame: 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 Outcome Measures :
  1. Pain due to the wound [ Time Frame: Change from baseline at 4, 8 and 12 weeks ]
    Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10.

  2. Wound size (wound reduction percentage) [ Time Frame: Baseline, 4, 8 and 12 weeks ]
    It will be evaluated by planimetry with PictZar 7.5 software

  3. Healing time [ Time Frame: Change from baseline at 4, 8 and 12 weeks ]
    This outcome will be measure by number of days until healing

  4. Complete wound healing (Resvech 2.0 score) [ Time Frame: 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

  5. Patient quality of life [ Time Frame: 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.

  6. Adverse Events [ Time Frame: Change from baseline at 4, 8 and 12 weeks ]
    Adverse events related with the treatment, referred by patients, caregivers or health professionals


Other Outcome Measures:
  1. Wound healing evolution [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667937


Contacts
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Contact: José Miguel Morales Asencio, PhD 0034951952833 jmmasen@uma.es
Contact: Juan Carlos Morilla Herrera, PhD jc.morilla.sspa@juntadeandalucía.es

Locations
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Spain
University of Málaga Not yet recruiting
Málaga, Spain, 29071
Contact: José Miguel Morales Asencio, PhD    0034951952833    jmmasen@uma.es   
Principal Investigator: José Miguel Morales Asencio, PhD         
Principal Investigator: Juan Carlos Morilla Herrera, PhD         
Sub-Investigator: Silvia García Mayor, PhD         
Sub-Investigator: Inmaculada Lupiáñez Pérez, PhD         
Sub-Investigator: José María García Cabello, PhD         
Sub-Investigator: Jorge Caro Bautista, PhD         
Sub-Investigator: Francisca Villa Estrada, PhD         
Sub-Investigator: Alfonso García Guerrero, PhD         
Sub-Investigator: Hilaria Vico Quintana, RN         
Sub-Investigator: Antonio Díez de los Ríos, RN         
Sub-Investigator: Eva María Pérez Madrigal, RN         
Sub-Investigator: María Lourdes Ruiz España, RN         
Sub-Investigator: Yolanda Pérez Espinosa, RN         
Sub-Investigator: Yolanda Rey Becerra, RN         
Sub-Investigator: María Carmen García Santamarina, RN         
Sub-Investigator: María Eugenia Valdés Planes, RN         
Sub-Investigator: Mario Carpena Del Pino, RN         
Sub-Investigator: Concepción Almoguera Gaviño, RN         
Sub-Investigator: Miguel Zaragoza Baquero, RN         
Sub-Investigator: Antonia María Santana Bra, RN         
Sub-Investigator: Mercedes Muñoz Conde, RN         
Sub-Investigator: Francisco Javier García Díaz, RN         
Sub-Investigator: Rafael Cabello Jaime, RN         
Sub-Investigator: Concepción Venegas Ariza, RN         
Sub-Investigator: María Del Carmen Expósito Alvarez, RN         
Sub-Investigator: Begoña Martín Muñoz, RN         
Sub-Investigator: Juan Carlos Toribio Montero, PhD         
Sub-Investigator: Marta Aranda Gallardo, PhD         
Sub-Investigator: Ana Belén Moya Suárez, PhD         
Sponsors and Collaborators
University of Malaga
BSN Medical GmbH
Andalusian Health Service
Investigators
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Principal Investigator: José Miguel Morales Asencio, PhD University of Malaga

Publications:
González-Consuegra, R.V., Verdú, J., 2010. Proceso de adaptación al castellano del Charing Cross Venous Ulcer Questionnaire (CCVUQ) para medir la calidad de vida relacionada con la salud en pacientes con úlceras venosas. Gerokomos 21, 80-87

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Responsible Party: JOSE MIGUEL MORALES ASENCIO, Head of the Department of Nursing. Professor of Research and Evidence Based Health Care, University of Malaga
ClinicalTrials.gov Identifier: NCT03667937     History of Changes
Other Study ID Numbers: CUCO-UV
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JOSE MIGUEL MORALES ASENCIO, University of Malaga:
Venous Ulcer
Leg Injuries
Bacterial Infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents