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.

Not Applicable

Completed

• Conditions: Dermal injury; Skin - Other skin conditions; Surgery - Other surgery; Injuries and Accidents - Burns; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001162101
• Lead Sponsor: PolyNovo Biomaterials Pty Ltd

Brief Summary

Various dermal substitutes exist and assist the management of patients where the full skin layer has been damaged/lost. They provide temporary wound closure and provide a scaffold for creation of a “neodermis” prior to final wound closure. NovoSorb BTM is a fully synthetic, biodegradable porous polyurethane foam surgical implant that provides temporary wound cover and a support for cells growth to help a wound heal. The study aim was to evaluate long-term safety and effectiveness of BTM in patients previously treated with BTM in wounds of at least 5% total body surface area with at least 1 device implanted. 15 patients were recruited who had BTM applied at least 18 months prior to the study. The injuries were primarily full thickness burns with patients aged 26-80 years and 13 were male. All patients underwent a standardised Physical examination and assessment of long-term scar quality for each BTM-treated lesion. Results demonstrated long-term safety and effectiveness of BTM in the treatment of adults with dermal injuries. No new long-term safety concerns were identified with no long-term risks detected. The results provide evidence that BTM can successfully integrate into the wound bed and provide a neodermis to support wound closure with good quality scar healing in the long term. Limitations of this study include a small number of patients, study delays from COVID-19 pandemic, the patient population was predominately male, Caucasian with full thickness burn injury.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Study Completion: 2021-05-21
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device safety as evaluated by the incidence of device-related adverse events/device effects, and device deficiencies as a composite primary outcome.[Single follow-up assessment at least 18 months after BTM application];Device performance as evaluated by per lesion assessment of scar quality after healing, measured by the Patient and Observer Scar Assessment Scale (POSAS). [Single follow-up assessment at least 18 months after BTM application.]

Secondary Outcome Measures

Name	Time	Method
il[Nil]