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

NCT03667937 | Unknown Phase 4 DMC

• 1 other identifier: CUCO-UV
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Venous Ulcer; Leg Injuries; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain due to the wound

  Change from baseline at 4, 8 and 12 weeks

• Wound size (wound reduction percentage)

  Baseline, 4, 8 and 12 weeks

• Healing time

  Change from baseline at 4, 8 and 12 weeks

• Complete wound healing (Resvech 2.0 score)

  Change from baseline at 4, 8 and 12 weeks

• Patient quality of life

  Change from baseline at 12 weeks

Other Outcomes (1)

• Wound healing evolution

  Baseline, 4, 8 and 12 weeks

Study Arms (2)

CUTIMED

EXPERIMENTAL

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

AQUACEL silver

ACTIVE COMPARATOR

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

Interventions

CUTIMED COMBINATION_PRODUCT

Hydrophobic Dressing

CUTIMED

AQUACEL silver OTHER

Silver Dressing

AQUACEL silver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• BSN Medical GmbH: collaborator
• Andalusian Health Service: collaborator

Study Sites (1)

University of Málaga

Málaga, 29071, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 27112627 BACKGROUND

• 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.

  PMID: 1366259 BACKGROUND

• 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.

  PMID: 17385590 BACKGROUND

• 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.

  PMID: 20671048 BACKGROUND

• 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.

  PMID: 26199888 BACKGROUND

• 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.

  PMID: 26833351 BACKGROUND

• 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.

  PMID: 28277989 BACKGROUND

• 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.

  PMID: 25879267 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer; Bacterial Infections; Leg Injuries

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Bacterial Infections and Mycoses; Infections; Wounds and Injuries

Study Officials

• José Miguel Morales Asencio, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Miguel Morales Asencio, PhD

CONTACT

0034951952833; jmmasen@uma.es

Juan Carlos Morilla Herrera, PhD

CONTACT

jc.morilla.sspa@juntadeandalucía.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Nursing. Professor of Research and Evidence Based Health Care

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: September 12, 2018
• Study Start: May 15, 2019
• Primary Completion: December 30, 2020
• Study Completion: April 30, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

ES (1)