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Trial registered on ANZCTR


Registration number
ACTRN12624000549527
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
1/05/2024
Date last updated
1/05/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
TetraDERM for Scar Reduction
Scientific title
A first in human study evaluating the safety and efficacy of TetraDERM device (a water-based solution) for scar management in subjects with a planned surgical procedure and surgical incision to the trunk, arm or legs
Secondary ID [1] 310528 0
TD-SR-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scar Management 331346 0
Condition category
Condition code
Surgery 328098 328098 0 0
Other surgery
Skin 330275 330275 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TetraDERM device is a water-based solution (hydrogel) that is directly applied to a surgical incision and it uses the natural heat from the body to form an elastic hydrogel scaffold, that controls moisture within the wound bed whilst providing a cushioning effect. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed may reduce scar formation.


Cohort 1 is open label and 8 participants will have a treatment planned that includes a surgical incision of greater than or equal to 3cm but less than or equal to 15cm in the areas of the chest, abdomen, pelvis and the back regions (trunk). legs and arms.
These participants will all receive the TetraDERM device once before the surgical incision is stitched to closure.
The dosage is 1ml of TetraDERM hydrogel per 10 cm length of surgical incision site.

The study duration involves a minimum of 11 clinical visits to the hospital over a period of 12 months. The investigational device will be applied at the investigator's clinic at Visit 2.

The screening visit is considered Visit 1 and may be up to 7 days prior to the surgery on Visit 2 (surgical procedure). Follow up will occur with the patient for up to 1 year. Visit 3 ( 1 week post operation), Week 4 (2 week post operation), Visit 5 (3 weeks post operation), Visit 6 (4 weeks post operation), Visit 7 (5 weeks post operation), Visit 8 (6 weeks post operation), Visit 9 (3 months post operation), Visit 10 (6 months post operation), Visit 11 (12 months post operations)
Intervention code [1] 326926 0
Treatment: Devices
Comparator / control treatment
Open label. All subjects will receive the Tetraderm device only. There is no placebo or standard of care comparison for this cohort.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335972 0
The safety and tolerability of the IP will be analysed via the safety reporting on study. the change in scarring measures at the surgical incision treated sites assessed at 6 weeks, and 6 months via the evaluated for evidence of any of the following signs/symptoms at each
assessment time point:
• Dehiscence
• Seroma
• Abnormal haematoma
• Infection
• Signs of allergic/intolerance response

The number and percentage of participants reporting each of the signs/symptoms at least once during the study, as well as at each specific assessment time will be summarized by treatment group and for all participants.
Timepoint [1] 335972 0
The composite outcome of the safety reporting and characteristics of the scarring will be completed using the Visit 8 / week 6 post-operatively and Visit 10 / 6 months post-operatively timepoints as compared to baseline.

Primary outcome [2] 335977 0
The following assessments will occur as a composite primary outcome with correlation to Cohort 2 and 3 data at the end of study: Cohort 2 and 3 will be registered in a separate ANZ CTR registration form.

Change of incidences of dehiscence (defined as partial or total separation of the previous approximated wound edges) or other clinical complications (seroma, abnormal haematoma and infection) related to the treated wound after 6 weeks follow up visit and 6 months follow up visits following treatment based on clinical observation at baseline.
Timepoint [2] 335977 0
Adverse Event data will be collected from the screening visit Visit 1, Visit 2 (surgical procedure). Follow up will occur with the patient for up to 1 year. Visit 3 ( 1 week post operation), Week 4 (2 week post operation), Visit 5 (3 weeks post operation), Visit 6 (4 weeks post operation), Visit 7 (5 weeks post operation), Visit 8 (6 weeks post operation), Visit 9 (3 months post operation), Visit 10 (6 months post operation), Visit 11 (12 months post operations)
Secondary outcome [1] 426320 0
Evaluate the extent of scar formation and characteristics at the incision site in using Vancouver Scar Scale (VSS) at all protocol required follow up intervals as compared to the corresponding Investigator assessments.
Timepoint [1] 426320 0
Visit 2 (following the surgical procedure), Visit 3 ( 1 week post operation), Week 4 (2 week post operation), Visit 5 (3 weeks post operation), Visit 6 (4 weeks post operation), Visit 7 (5 weeks post operation), Visit 8 (6 weeks post operation), Visit 9 (3 months post operation), Visit 10 (6 months post operation), Visit 11 (12 months post operations)
Secondary outcome [2] 426321 0
Evaluate the extent of scar formation and characteristics at the incision site in using Clinical Photography at all protocol required follow up intervals as compared to the corresponding Investigator assessments.
Timepoint [2] 426321 0
Visit 2 (following the surgical procedure), Visit 3 ( 1 week post operation), Week 4 (2 week post operation), Visit 5 (3 weeks post operation), Visit 6 (4 weeks post operation), Visit 7 (5 weeks post operation), Visit 8 (6 weeks post operation), Visit 9 (3 months post operation), Visit 10 (6 months post operation), Visit 11 (12 months post operations)

Eligibility
Key inclusion criteria
1. Subject or legally authorised representative must sign an Informed Consent Form(ICF) indicating that he/she/they understand the purpose of, and procedures required for the study and is willing to participate for the entire duration.
2. In the Investigator’s opinion, the subject is able to understand and comply with the protocol requirements and is likely to complete the study as planned.
3. Female subjects must have a negative serum (ß human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy test prior to procedure.
4. Male subjects must use adequate contraception (as defined in the informed consent) from Screening and throughout the duration of the study and 12 month follow up period.
5. Subject may have a BMI of 18.0 to 35.0 kg/m2, extremes included.
6. Subjects between the age of 18 and 75 years at the time of enrollment.
7. Subjects who have treatment planned that includes a surgical incision equal to 3cm and equal or less than 15cm, in areas on the trunk, limbs and arms.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with surgical incisions with expected wound length that do not meet their cohort criteria.
2. Subjects who require more than 1 surgical incision.
3. Subjects with surgical incisions with expected wound length that in total exceeds 1.8 m (180 cm).
4. Subjects with acute infection at the target site or a surgical site located near infection.
5. Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
6. Subjects with a positive drug screen including amphetamines, benzodiazepines, cocaine, opioids, methadone and barbiturates for the duration of the study.
7. Subjects who smoke tobacco.
8. Subjects who are concurrently enrolled in another clinical study, or who have or received an investigational device or drug within the past eight (8) weeks.
9. Subjects with a history of a psychological illness or condition such as to interfere with the Subject's ability to understand the requirements of the study.
10. Subjects with diagnosed fibromyalgia.
11. Subjects unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
12. Subjects who are undergoing or are planned to undergo an immunosuppressive therapy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
secure password protected randomization schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Given the composite review and analysis that will be performed at the end of the overall study (Once Cohort 1, 2 & 3 are complete). Please note: Cohort 2 and 3 will be registered in a separate ANZ CTR form, then the Sponsor will finalize a Statistical Analysis Plan (SAP) detailing all planned analyses. Any analyses conducted in addition to those specified in the SAP will be clearly documented as post hoc.
Quantitative variables will be summarized descriptively using number of subjects (n), mean, standard deviation, median, minimum, and maximum. Qualitative variables will be summarized using counts and percentages.
Summaries will be provided for demographics, baseline medical history, concurrent therapies, and subject disposition.
All analyses will be two-sided at a significance level of 0.05. The 95% confidence intervals will be provided where appropriate.
The SAP will serve as the final determinant of the statistical procedures, notwithstanding anything herein.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/05/2024
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314730 0
Commercial sector/Industry
Name [1] 314730 0
Tetratherix Technology Pty Ltd
Country [1] 314730 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tetratherix Technology Pty Ltd
Address
29/34-36 Ralph Street, NSW 2015 Australia
Country
Australia
Secondary sponsor category [1] 316716 0
None
Name [1] 316716 0
Address [1] 316716 0
Country [1] 316716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313741 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313741 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 313741 0
Australia
Date submitted for ethics approval [1] 313741 0
09/04/2024
Approval date [1] 313741 0
26/04/2024
Ethics approval number [1] 313741 0

Summary
Brief summary
The purpose of this study is to evaluate the extent of scar formation and to provide safety information for a new approach to scar formation after s surgical procedure.

TetraDERM device uses the natural heat from the body to form an elastic hydrogel scaffold, the controls moisture within the wound bed whilst providing a cushioning effect physically to reduce the tension of the wound. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed, to reduce wound tension and support healing work to reduce scar formation.

Up to 8 subjects will be enrolled at one clinical site in Australia in cohort 1. There will be a total of 11 subject visits occurring over 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129202 0
Dr Drew Cronin
Address 129202 0
The Coastal Clinic Plastic Surgery & Aesthetics Suite 5.2B, Level 5, 123 Nerang Street, Southport QLD 4215
Country 129202 0
Australia
Phone 129202 0
+61 07 5683 4215
Fax 129202 0
Email 129202 0
[email protected]
Contact person for public queries
Name 129203 0
Ali Fathi
Address 129203 0
Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
Country 129203 0
Australia
Phone 129203 0
+614 1372 1939
Fax 129203 0
Email 129203 0
[email protected]
Contact person for scientific queries
Name 129204 0
Ali Fathi
Address 129204 0
Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
Country 129204 0
Australia
Phone 129204 0
+614 1372 1939
Fax 129204 0
Email 129204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient and company confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.