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

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

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

Study Overview

• Status: Unknown
• Conditions: Bacterial Infections; Venous Leg Ulcer; Chronic Ulcer of Skin of Lower Limb Nos
• Intervention / Treatment: Combination product: CUTIMED; Other: AQUACEL silver

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®.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29071
    • Recruiting
    • University of Malaga
    • Contact: José Miguel Morales Asencio, PhD; Phone Number: 0034951952833; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing evolution	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	Baseline, 4, 8 and 12 weeks

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: BSN Medical GmbH; Andalusian Health Service
• Investigators: Principal Investigator: José Miguel Morales Asencio, PhD, University of Malaga

Publications and helpful links

General Publications

• Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
• Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502.
• Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. J Wound Care. 2007 Mar;16(3):129-32. doi: 10.12968/jowc.2007.16.3.27015.
• Moore K, Hall V, Paull A, Morris T, Brown S, McCulloch D, Richardson MC, Harding KG. Surface bacteriology of venous leg ulcers and healing outcome. J Clin Pathol. 2010 Sep;63(9):830-4. doi: 10.1136/jcp.2010.077032. Epub 2010 Jul 29.
• Moore MF. Prospective, Descriptive Study of Critically Colonized Venous Leg Ulcers Managed With Silver Containing Absorbent Dressings and Compression. J Am Coll Clin Wound Spec. 2014 Sep 16;5(2):36-9. doi: 10.1016/j.jccw.2014.08.002. eCollection 2013 Aug.
• Pugliese DJ. Infection in Venous Leg Ulcers: Considerations for Optimal Management in the Elderly. Drugs Aging. 2016 Feb;33(2):87-96. doi: 10.1007/s40266-016-0343-8.
• Totty JP, Bua N, Smith GE, Harwood AE, Carradice D, Wallace T, Chetter IC. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. J Wound Care. 2017 Mar 2;26(3):107-114. doi: 10.12968/jowc.2017.26.3.107.
• Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011 Sep;23(9):267-75.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Bacterial Infections; Venous Ulcer; Leg Injuries
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease Attributes; Skin Ulcer; Bacterial Infections and Mycoses; Varicose Veins; Ulcer; Infections; Communicable Diseases; Bacterial Infections; Leg Ulcer; Varicose Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CUCO-UV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No