N/A
N=14
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Burns
Bottom Line
View on ClinicalTrials.gov: NCT02905435 ↗Enrolled (actual)
14
Serious AEs
42.9%
Results posted
Jun 2021
Primary outcome: Primary: BTM 'Take' Rate — 95.22 percentage of BTM take per subject
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biodegradable Temporizing Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BTM 'Take' Rate |
95.22 | — |
| PRIMARY SSG 'Take' Rate Over BTM |
97.53 | — |
| PRIMARY Adverse Events |
340; 3; 8; 3; 6; 2 | — |
| SECONDARY Infection |
21; 12; 7; 2; 3 | — |
| SECONDARY Wound Closure - Anterior Torso |
99.8; 99.8; 99.8; 100.0; 100 | — |
| SECONDARY Wound Closure - Left Lower Limb |
95.8; 95.8; 100; 100; 100 | — |
| SECONDARY Wound Closure - Left Upper Limb |
100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Wound Closure - Posterior Torso |
94.8; 95.8; 100.0; 100.0; 99.6 | — |
| SECONDARY Wound Closure - Right Lower Limb |
96.0; 96.3; 99.8; 99.8; 99.7 | — |
| SECONDARY Ease of Use: "BTM is Easy to Use" |
2.0; 1.0; 1.7; 1.0 | — |
| SECONDARY Ease of Use: "BTM is Easy to Apply" |
2.0; 1.0; 1.8; 1.0 | — |
| SECONDARY Ease of Use: "BTM is Easy to Delaminate" |
1.0; 1.0; 1.2; 1.0 | — |
| SECONDARY Ease of Use: "BTM is a Product I Would Use for Other Burn Patients" |
2.0; 1.0; 1.3; 1.0 | — |
| SECONDARY Joint Contracture |
2; 1; 1; 2; 1; 1 | — |
| SECONDARY Scar Severity |
7.3; 7.7; 6.7; 6.4; 4.5 | — |
| SECONDARY Skin Itch |
2.8; 2.4; 3.3; 3.7; 4.4 | — |
Summary
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of a new method of treating skin burns using Biodegradable Temporizing Matrix (BTM).
Eligibility Criteria
Inclusion Criteria
- Provides written informed consent (directly or via legal representative) prior to any clinical trial procedures being performed.
- Willing to comply with all study procedures and expects to be available for the duration of the study.
- Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age.
- Patients with deep partial or full thickness burns (between 10% and 70% inclusive of their TBSA).
Exclusion Criteria
- Has a known hypersensitivity to polyurethane or silver-containing materials.
- Multiple traumas (significant traumatic injury to a solid organ in addition to skin).
- Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy.
- Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound.
- Female with known or suspected pregnancy, planned pregnancy, or lactation.
- Has had exposure to any other investigational agent within the last 6 months.
- Has a clinically significant psychiatric illness.
- Has a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
Data sourced from ClinicalTrials.gov (NCT02905435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.