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

Phase 4

• Conditions: Chronic Ulcer of Skin of Lower Limb Nos; Bacterial Infections; Venous Leg Ulcer
• Interventions: Combination Product: CUTIMED; Other: AQUACEL silver

• Registration Number: NCT03667937
• Lead Sponsor: University of Malaga

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®.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Study Start: 2019-05-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-12-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CUTIMED	CUTIMED	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).
AQUACEL silver	AQUACEL silver	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).

Primary Outcome Measures

Name	Time	Method
Microorganisms' Colonization Level	Change from baseline, at 4, 8 and 12 weeks	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

Name	Time	Method
Pain due to the wound	Change from baseline at 4, 8 and 12 weeks	Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10.
Healing time	Change from baseline at 4, 8 and 12 weeks	This outcome will be measure by number of days until healing
Patient quality of life	Change from baseline at 12 weeks	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.
Wound size (wound reduction percentage)	Baseline, 4, 8 and 12 weeks	It will be evaluated by planimetry with PictZar 7.5 software
Adverse Events	Change from baseline at 4, 8 and 12 weeks	Adverse events related with the treatment, referred by patients, caregivers or health professionals
Complete wound healing (Resvech 2.0 score)	Change from baseline at 4, 8 and 12 weeks	Complete healing will be considered with a 0 score in the fourth dimension of the Resvech 2.0 scale

Trial Locations

Locations (1)

University of Málaga; 🇪🇸 Málaga, Spain