Clinical trial NCT03667937: Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Venous Leg Ulcer
Bacterial Infections
Chronic Ulcer of Skin of Lower Limb Nos
Keywords: Venous Ulcer
Leg Injuries
Bacterial Infections
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: BSN Medical GmbH
name: Andalusian Health Service
First posted: 2018-09-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

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:

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.

Primary outcomes:
measure: Microorganisms' Colonization Level
timeFrame: Change from baseline, at 4, 8 and 12 weeks
Secondary outcomes:
measure: Pain due to the wound
timeFrame: Change from baseline at 4, 8 and 12 weeks
measure: Wound size (wound reduction percentage)
timeFrame: Baseline, 4, 8 and 12 weeks
measure: Healing time
timeFrame: Change from baseline at 4, 8 and 12 weeks
measure: Complete wound healing (Resvech 2.0 score)
timeFrame: Change from baseline at 4, 8 and 12 weeks
measure: Patient quality of life
timeFrame: Change from baseline at 12 weeks
measure: Adverse Events
timeFrame: Change from baseline at 4, 8 and 12 weeks
Other outcomes:
measure: Wound healing evolution
timeFrame: Baseline, 4, 8 and 12 weeks
Locations:
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
affiliation: University of Malaga
name: José Miguel Morales Asencio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.12968/jowc.2007.16.3.27015.
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.
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.
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.
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.
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.
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