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

Bacterial Infections Clinical Trial

— CUCO-UV  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667937
• Other study ID #: CUCO-UV
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2020
• Source: University of Malaga
• Contact: José Miguel Morales Asencio, PhD
• Phone: 0034951952833
• Email: jmmasen[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: April 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Chronic Ulcer of Skin of Lower Limb Nos
• Communicable Diseases
• Infection
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Combination Product:
• CUTIMED
Hydrophobic Dressing

Other:
• AQUACEL silver
Silver Dressing

Locations

Country	Name	City	State
Spain	University of Málaga	Málaga

Sponsors (3)

Lead Sponsor	Collaborator
University of Malaga	Andalusian Health Service, BSN Medical GmbH

Country where clinical trial is conducted

Spain, 

References & Publications (9)

González de la Torre H, Quintana-Lorenzo ML, Perdomo-Pérez E, Verdú 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. — View Citation

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

Hansson L, Hedner T, Dahlöf 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Wound size (wound reduction percentage)	It will be evaluated by planimetry with PictZar 7.5 software	Baseline, 4, 8 and 12 weeks
Secondary	Healing time	This outcome will be measure by number of days until healing	Change from baseline at 4, 8 and 12 weeks
Secondary	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
Secondary	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
Secondary	Adverse Events	Adverse events related with the treatment, referred by patients, caregivers or health professionals	Change from baseline at 4, 8 and 12 weeks