Wounds
Conditions
Interventions
This is an experimental phase I clinical study, double-blind and randomized. Thus, the progression of a group of volunteers who will undergo the topical application of bacterial nanocellulose hydrogel
in a circular area corresponding to 4 cm2, and subsequently, a polyurethane film will be placed over the site to prevent the hydrogel from being removed during bathing, movement, or clothing use. Part
V03.175.250.100
Sponsors
Faculdade de Enfermagem - Universidade Federal de Juiz de Fora
Faculdade de Enfermagem - Universidade Federal de Juiz de Fora
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults aged above 18 and below 60 years; of both sexes
Exclusion criteria
Exclusion criteria: Adults without a history of infectious or parasitic diseases, infectious processes, or allergy to the components of the formulation; without the use of antimicrobials, immunosuppressants, systemic corticosteroids, and antiallergic and anti-inflammatory drugs in the last 15 days; pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of the safety of topical application of bacterial nanocellulose hydrogel with Poly-L-Lysine-Cholesterol (BNC-PLC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimization of the production of bacterial nanocellulose hydrogels incorporated with Poly-L-Lysine-Cholesterol for the purpose of topical application; absence of adverse effects and inflammatory signs from the topical application of BNC-PLC hydrogel on intact skin of healthy individuals through the execution of a Phase 1 clinical trial | — |
Countries
Brazil
Contacts
Public ContactThiago Nascimento
Universidade Federal de Juiz de Fora
Outcome results
None listed