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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

CUTIMED

AQUACEL silver

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous Ulcer, Leg Injuries, Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Severe pain during dressing change
Perilesional edema.
Local edema.
Unpleasant smell.
Abundant pus
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.

Sites / Locations

University of MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CUTIMED

AQUACEL silver

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain due to the wound

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

Wound size (wound reduction percentage)

It will be evaluated by planimetry with PictZar 7.5 software

Healing time

This outcome will be measure by number of days until healing

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

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.

Adverse Events

Adverse events related with the treatment, referred by patients, caregivers or health professionals

Full Information

NCT ID

NCT03667937

First Posted

May 24, 2018

Last Updated

March 23, 2020

Sponsor

University of Malaga

Collaborators

BSN Medical GmbH, Andalusian Health Service

1. Study Identification

Unique Protocol Identification Number

NCT03667937

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Malaga

Collaborators

BSN Medical GmbH, Andalusian Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Venous Ulcer, Leg Injuries, Bacterial Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CUTIMED

Arm Type

Experimental

Arm Description

Arm Title

AQUACEL silver

Arm Type

Active Comparator

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

CUTIMED

Intervention Description

Hydrophobic Dressing

Intervention Type

Other

Intervention Name(s)

AQUACEL silver

Intervention Description

Silver Dressing

Primary Outcome Measure Information:

Title

Microorganisms' Colonization Level

Description

Time Frame

Change from baseline, at 4, 8 and 12 weeks

Secondary Outcome Measure Information:

Title

Pain due to the wound

Description

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

Time Frame

Change from baseline at 4, 8 and 12 weeks

Title

Wound size (wound reduction percentage)

Description

It will be evaluated by planimetry with PictZar 7.5 software

Time Frame

Baseline, 4, 8 and 12 weeks

Title

Healing time

Description

This outcome will be measure by number of days until healing

Time Frame

Change from baseline at 4, 8 and 12 weeks

Title

Complete wound healing (Resvech 2.0 score)

Description

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

Title

Patient quality of life

Description

Time Frame

Change from baseline at 12 weeks

Title

Adverse Events

Description

Adverse events related with the treatment, referred by patients, caregivers or health professionals

Time Frame

Change from baseline at 4, 8 and 12 weeks

Other Pre-specified Outcome Measures:

Title

Wound healing evolution

Description

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

Time Frame

Baseline, 4, 8 and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: Severe pain during dressing change Perilesional edema. Local edema. Unpleasant smell. Abundant pus 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

José Miguel Morales Asencio, PhD

Phone

0034951952833

jmmasen@uma.es

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Carlos Morilla Herrera, PhD

jc.morilla.sspa@juntadeandalucía.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Miguel Morales Asencio, PhD

Organizational Affiliation

University of Malaga

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Málaga

City

Málaga

ZIP/Postal Code

29071

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Miguel Morales Asencio, PhD

Phone

0034951952833

jmmasen@uma.es

First Name & Middle Initial & Last Name & Degree

José Miguel Morales Asencio, PhD

First Name & Middle Initial & Last Name & Degree

Juan Carlos Morilla Herrera, PhD

First Name & Middle Initial & Last Name & Degree

Silvia García Mayor, PhD

First Name & Middle Initial & Last Name & Degree

Inmaculada Lupiáñez Pérez, PhD

First Name & Middle Initial & Last Name & Degree

José María García Cabello, PhD

First Name & Middle Initial & Last Name & Degree

Jorge Caro Bautista, PhD

First Name & Middle Initial & Last Name & Degree

Francisca Villa Estrada, PhD

First Name & Middle Initial & Last Name & Degree

Alfonso García Guerrero, PhD

First Name & Middle Initial & Last Name & Degree

Hilaria Vico Quintana, RN

First Name & Middle Initial & Last Name & Degree

Antonio Díez de los Ríos, RN

First Name & Middle Initial & Last Name & Degree

Eva María Pérez Madrigal, RN

First Name & Middle Initial & Last Name & Degree

María Lourdes Ruiz España, RN

First Name & Middle Initial & Last Name & Degree

Yolanda Pérez Espinosa, RN

First Name & Middle Initial & Last Name & Degree

Yolanda Rey Becerra, RN

First Name & Middle Initial & Last Name & Degree

María Carmen García Santamarina, RN

First Name & Middle Initial & Last Name & Degree

María Eugenia Valdés Planes, RN

First Name & Middle Initial & Last Name & Degree

Mario Carpena Del Pino, RN

First Name & Middle Initial & Last Name & Degree

Concepción Almoguera Gaviño, RN

First Name & Middle Initial & Last Name & Degree

Miguel Zaragoza Baquero, RN

First Name & Middle Initial & Last Name & Degree

Antonia María Santana Bra, RN

First Name & Middle Initial & Last Name & Degree

Mercedes Muñoz Conde, RN

First Name & Middle Initial & Last Name & Degree

Francisco Javier García Díaz, RN

First Name & Middle Initial & Last Name & Degree

Rafael Cabello Jaime, RN

First Name & Middle Initial & Last Name & Degree

Concepción Venegas Ariza, RN

First Name & Middle Initial & Last Name & Degree

María Del Carmen Expósito Alvarez, RN

First Name & Middle Initial & Last Name & Degree

Begoña Martín Muñoz, RN

First Name & Middle Initial & Last Name & Degree

Juan Carlos Toribio Montero, PhD

First Name & Middle Initial & Last Name & Degree

Marta Aranda Gallardo, PhD

First Name & Middle Initial & Last Name & Degree

Ana Belén Moya Suárez, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

27112627

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.

Results Reference

background

PubMed Identifier

1366259

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.

Results Reference

background

PubMed Identifier

17385590

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.

Results Reference

background

PubMed Identifier

20671048

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.

Results Reference

background

PubMed Identifier

26199888

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.

Results Reference

background

PubMed Identifier

26833351

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.

Results Reference

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PubMed Identifier

28277989

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.

Results Reference

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PubMed Identifier

25879267

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.

Results Reference

background

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

Results Reference

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

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