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Randomized Clinical Trial on Hydrofiber with Extra Silver in the Treatment of a Patient with Venous Ulcers

Randomized comparative study between Aquacel and Safgel in the treatment of a patient with Venous Ulcers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-6cvt9p
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compressive Banning

Interventions

Elastic Bandage + Silver Carboxymethyl Cellulose Group: 20 participants with venous ulcers. Elastic Bandage + Hydrogel with Alginate Group: 20 participants with venous ulcers. All dressings will be ma
Device

Sponsors

Universidade Guarulhos
Lead Sponsor
Universidade Guarulhos
Collaborator
Luiz Fernando Fogaça
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: between 18 and 80 years;diagnosis of one or more venous ulcers on any lower limb, being venous; with palpable pulses;recent ulcers with a minimum of six weeks on the lower limb; understanding of the guidelines made by the researcher, to ensure continuity of treatment.

Exclusion criteria

Exclusion criteria: the therapeutic regimen of use for venous ulcers in the lower limb; arterial and \ or mixed injuries; with circular lesions in the lower limbs, with distal pulses not palpable; pregnant patients and infants; diabetic patients; with a history of using illegal substances and \ or; with a history of mental disorder (identified in the medical record by a doctor).

Design outcomes

Primary

MeasureTime frame
Evaluate the epithelialization of venous ulcer tissue after dressing with the respective materials used: Hydrofiber with silver and Hydrogel with Calcium Alginate.

Secondary

MeasureTime frame
Evaluate through the instruments mentioned as: Numerical Pain Scale, Pain Management Index, Brief Pain Inventory, BIQLI - Body Image Quality of Life, Rosenberg Self-Esteem Scale - EARG and Pusch - Pressure Ulcer Sclae for Healing, if participants show improvements in the questionnaires through the dressings in the groups .

Countries

Brazil

Contacts

Public ContactLuiz;Luiz Fogaça;Fogaça

Universidade Guarulhos;Universidade Guarulhos

luizfogaca@fho.edu.br;luizfogaca@fho.edu.br55-019-99772-7231;(011)2464-1700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)