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

University of Malaga

Status and phase: Unknown; Phase 4

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

Treatments: Combination Product: CUTIMED; Other: AQUACEL silver

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03667937

CUCO-UV

Details and patient eligibility

About

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

Full 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®.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

CUTIMED

Experimental group

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).

Treatment:

Combination Product: CUTIMED

AQUACEL silver

Active Comparator group

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 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).

Treatment:

Other: AQUACEL silver