Skip to content

Evaluation of the healing potential of PolyTissue® dressing in the treatment of burns.

Clinical evaluation of PolyTissue® Film and/or Hydrogel in the treatment of Burns.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-323k7by
Enrollment
150
Registered
2026-04-13
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Scalding Burn

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial consisting of 150 participants, where 75 patients will be selected for the study group (where PolyTissue® film and/or hydrogel wil

Sponsors

Hospital da Restauração
Lead Sponsor
Polisa Biopolimeros para a saúde
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children, adolescents, and adults, with no age limit; of any gender; diagnosed with first and/or second-degree burns

Exclusion criteria

Exclusion criteria: Participants who do not return for clinical reassessment; who present with clinical complications; who have associated diseases; who have contraindications for the use of dressings; who have very deep burns; who have third-degree burns; burns requiring skin grafting; infected burns

Design outcomes

Primary

MeasureTime frame
Characterize the sociodemographic profile of burn patients included in the study; Perform clinical evaluation at all stages of the research protocol using the MEASURE method; Stratify the risk/severity of the subjects involved in the study, considering the sociodemographic profile, clinical condition, and epidemiological profile; Measure the average healing time of burns in the groups using statistical analysis standards; Monitor, record, and measure, through photography, the evolution of the burn healing process at all dressing change times in both the control and experimental groups using the imitoMeasure® application.

Secondary

MeasureTime frame
No secondary stages are expected.

Countries

BR

Contacts

Public ContactLayla Mahnke

Universidade Federal de Pernambuco

laylacm@gmail.com+55(81)99529-3525

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026