Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
NCT ID: NCT04793074
Last Updated: 2021-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2019-07-01
2020-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Transforming nanoparticle dressing
Patients in the treatment group (n=30) had transforming nanoparticle dressing
Transforming nanoparticle dressing
Transforming nanoparticle dressing
Conventional compression dressing
The control group (n=30) received conventional compression dressing.
Conventional compression dressing
Conventional compression dressing
Interventions
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Transforming nanoparticle dressing
Transforming nanoparticle dressing
Conventional compression dressing
Conventional compression dressing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
70 Years
ALL
No
Sponsors
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Egyptian Biomedical Research Network
NETWORK
Responsible Party
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Principal Investigators
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Barakat Abdelreheem
Role: PRINCIPAL_INVESTIGATOR
Helwan University
Locations
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Helwan University
Helwan, , Egypt
Countries
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References
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Mahmood BA, ElSayed EH, Abd Elghany SM, Elnaggar DF, Youssef HAA, Abdelmaksoud SM. A New Powder Dressing for Management of Chronic Venous Ulcers. Dermatol Surg. 2023 Jul 1;49(7):664-668. doi: 10.1097/DSS.0000000000003812. Epub 2023 Apr 25.
Other Identifiers
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EBRN080321
Identifier Type: -
Identifier Source: org_study_id
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