A study to assess the long-term safety and performance of patients previously treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for the repair of skin injuries.

Long-term safety and effectiveness evaluation of participants treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for dermal repair: An observational cohort study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001162101

Enrollment

Registered

2019-08-20

Start date

2021-02-26

Completion date

2021-05-21

Last updated

2022-02-28

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

Conditions

None listed

Brief summary

PolyNovo Biomaterials Pty Ltd has developed a new medical device, NovoSorb® Biodegradable Temporising Matrix (BTM), BTM is a skin substitute used to treat patients who need their wounds to be covered after an injury such as a deep burn, an accident where the skin has been damaged, or a severe skin infection. This study will assess the long-term safety and performance in patients where BTM was applied to at least 5% of their body at least 18 months ago. Patients will be asked to return to their hospital where a surgeon will examine them to assess their current health. Areas of the body where BTM was applied will also be examined by the surgeon. Patients will also assess the areas treated with BTM.

Interventions

This post-marketing clinical follow-up study aims to evaluate the long-term (>= 18 months) safety and effectiveness of BTM in patients previously treated for dermal repair involving >= 5% total body surface area (TBSA) of device coverage and more than one device implanted. A single study visit, estimated to take 60 minutes. will be conducted including documenting current health status, physical examination, assessment of areas where BTM was applied, and completion of questionnaires by the clinic

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

1. Patient must have had BTM device(s) implanted for a period of at least 18 months 2. Patient must have had BTM device coverage of >= 5% TBSA 3. Patient agrees and is able to take part in the follow-up visit and assessments 4. Patient provides written, informed consent

Exclusion criteria

1. Patient was last treated with BTM device(s) < 18 months ago 2. Patient was treated with BTM device(s) with < 5% TBSA coverage 3. Patient has expressed a refusal to participate

Outcome results