Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers

Egyptian Biomedical Research Network

Status and phase: Completed; Phase 4

Conditions: Chronic Venous Hypertension With Ulcer

Treatments: Combination Product: Transforming nanoparticle dressing; Combination Product: Conventional compression dressing

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04793074

EBRN080321

Details and patient eligibility

About

The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

Full description

The present randomized controlled study was conducted at Helwan University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee and all patients gave informed consent before enrollment.

The study included 60 patients with CVU. Patients were diagnosed on the basis of clinical findings and vascular Doppler ultrasonography. Exclusion criteria were associated infection and associated ulcers of other etiologies. Patients randomization was achieved using computer generated numbers and sealed envelope technique. Randomization and patients' allocation to the study interventions was performed by an independent researcher who wasn't aware of the study interventions and outcome.

Upon recruitment, patients were subjected to careful history taking, thorough clinical examination, standard laboratory investigations and vascular ultrasound examination. The recorded parameters included demographic data (age, sex and body mass index), associated morbidities, duration and size of CVU and history of previous interventions.

After randomization, patients in the treatment group (n=30) had transforming nanoparticle dressing while the control group (n=30) received conventional compression dressing. Before applications of both dressings, the wound area was thoroughly cleaned. In the treatment group, the dressing powder was applied as a thin layer to the ulcer surface. Any excess powder surrounding the ulcer area was removed. In both groups, a secondary protective gauze dressing was applied. Patients were follow up at weekly intervals until complete healing occurs.

The primary end-point in the present study is the time to complete healing. The secondary end-point the rate of healing (percent of reduction in ulcer area).

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic venous ulcers.

Exclusion criteria

• Associated infection and associated ulcers of other etiologies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Transforming nanoparticle dressing

Experimental group

Description:

Patients in the treatment group (n=30) had transforming nanoparticle dressing

Treatment:

Combination Product: Transforming nanoparticle dressing

Conventional compression dressing

Active Comparator group

Description:

The control group (n=30) received conventional compression dressing.

Treatment:

Combination Product: Conventional compression dressing