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Evaluation of absorbable Dressing containing Red Propolis for use in chronic Wound: clinical study

Evaluation of bioactive Dressing containing Red Propolis Extract or Red Propolis Wax for use in chronic Wounds: clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10ms8yjv
Enrollment
Unknown
Registered
2023-06-13
Start date
2023-05-15
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

Wounds and Injuries

Interventions

This is a five-arm, blind, randomized controlled clinical study. A total of 100 people who meet the eligibility criteria. Experimental group: 20 participants of both sexes, aged over 18, will be rando
E07.206.627

Sponsors

Universidade Federal de Alagoas
Lead Sponsor
Universidade Federal de Alagoas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum age of 18 years. Volunteers with chronic venous injury using unna boot compression or elastic therapy. Surface area up to 150 cm2. Wound covered with > 50% granulation tissue, no black necrotic tissue on the wound surface, and spaced > 3cm from any wound edge to another wound located on the same limb. Both genders. Variable nutritional status and hydration. They may carry the most varied clinical pathologies

Exclusion criteria

Exclusion criteria: Hypersensitivity to one of the dressing components, poor health, body mass index (BMI) in the grade 3 obesity range, erysipelas, cellulitis, lymphangitis, chronic lymphedema. Malignant wound degeneration or neoplastic lesion treated by radiotherapy, chemotherapy and immunosuppressive drugs or corticosteroid dose. Clinically infected lesion requiring a systemic antibiotic. History of deep or superficial venous thrombosis in the previous three months. Have undergone surgery directly related to venous insufficiency within two months prior to inclusion. Wound surgery planned during the trial period. Patients who are in the terminal phase will not be included in the study

Design outcomes

Primary

MeasureTime frame
Evaluate the healing of chronic wounds with the use of bioactive dressings containing polycaprolactone, propolis extract or wax. Using the Anova test method with post hoc (Tukey) HSD or Kruskal-Wallis Test with Dunn post hoc depending on the homoscedasticity of the variables

Secondary

MeasureTime frame
Assess the pain in the wound. Using the visual analogue scale (VAS);Expected to find a decrease in wound exudate

Countries

Brazil

Contacts

Public ContactAlba Thomé

Universidade Federal de Alagoas

regina.cartaxo@outlook.com+55(82)32141684

Outcome results

None listed

Source: REBEC (via WHO ICTRP)