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Trial registered on ANZCTR


Registration number
ACTRN12624000965505
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
8/08/2024
Date last updated
25/08/2024
Date data sharing statement initially provided
8/08/2024
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] 312475 0
TD-SR-001
Universal Trial Number (UTN)
Trial acronym
Linked study record
This ANZCTR registration is for cohort 2 and 3 of the already registered trial with the trial ID: ACTRN12624000549527 that is for cohort 1.

Health condition
Health condition(s) or problem(s) studied:
Scar Management 334505 0
Condition category
Condition code
Surgery 331119 331119 0 0
Other surgery
Skin 331120 331120 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.

A separate ANZCTR registration was completed for cohort 1. This ANZCTR registration is for cohort 2 and 3.

Cohort 2 is a randomised, participant blinded, study of up to 18 participants who 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 face or neck, Participants are randomised to the ratio of 2 to 1 to determine if the target wound will be treated with TetraDERM hydrogel (IP) or standard of care (SOC). i.e 12 participants are allocated to TetraDERM hydrogel and 6 participants to the Standard of Care Control group.

Cohort 3 is a randomised, participant-blinded study of up to 27 participants with planned surgical incisions cumulatively accounting to no greater than 180cm in length after bilateral breast reduction (mastopexy) and/or abdominoplasty, circumferential lipectomy and/or bilateral thigh reduction and/or bilateral arm reduction surgeries to be treated with TetraDERM hydrogel or standard of care. Participants are randomised to the ratio of 2 to 1. i.e 18 participants are allocated to TetraDERM and 9 participants to the control group.

The dosage is 1ml of TetraDERM hydrogel per 10cm 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 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] 329100 0
Treatment: Devices
Comparator / control treatment
Standard of Care (SOC) - participants allocated to SOC will have identical primary closure/suturing approaches as those allocated to IP, the only difference is that they will not have the IP TetraDERM applied into the wound interface between the two layers.

Post operative care of participants in IP and Standard of Care Group are identical and per PI's Standard of Care,

Control group
Placebo

Outcomes
Primary outcome [1] 338903 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
Timepoint [1] 338903 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] 338904 0
The following assessments will occur as a composite primary outcome with correlation to Cohort 2 and 3 data at the end of study. 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] 338904 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] 437885 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] 437885 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] 437886 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] 437886 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.

Cohort 2 Only
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 face and neck.

Cohort 3 only
6. Subjects between the age of 18 and 75 years at the time of enrollment.
7. Participants that have treatment planned that includes bilateral breast reduction (mastopexy or Wise Pattern) and/or abdominoplasty and/or Circumferential lipectomy and/or bilateral thigh reduction and bilateral arm reduction surgeries.
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Secure password protected randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An Electronic Data Capture system will generate a randomisation number that will be assigned to the participant. This randomisation number will correlate with a provided randomisation list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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). 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
Recruiting
Date of first participant enrolment
Anticipated
18/09/2024
Actual
Date of last participant enrolment
Anticipated
10/07/2025
Actual
Date of last data collection
Anticipated
10/07/2026
Actual
Sample size
Target
45
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316893 0
Commercial sector/Industry
Name [1] 316893 0
Tetratherix Technology Pty Ltd
Country [1] 316893 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tetratherix Technology Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319143 0
None
Name [1] 319143 0
Address [1] 319143 0
Country [1] 319143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315655 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315655 0
Ethics committee country [1] 315655 0
Australia
Date submitted for ethics approval [1] 315655 0
09/04/2024
Approval date [1] 315655 0
26/04/2024
Ethics approval number [1] 315655 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135390 0
Dr Drew Cronin
Address 135390 0
The Coastal Clinic Plastic Surgery & Aesthetics Suite 5.2B, Level 5, 123 Nerang Street, Southport QLD 4215
Country 135390 0
Australia
Phone 135390 0
+61 07 5683 4215
Fax 135390 0
Email 135390 0
drcronin@thecoastalclinic.com.au
Contact person for public queries
Name 135391 0
Ali Fathi
Address 135391 0
Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
Country 135391 0
Australia
Phone 135391 0
+61 4 1372 1939
Fax 135391 0
Email 135391 0
ali.fathi@tetratherix.com
Contact person for scientific queries
Name 135392 0
Ali Fathi
Address 135392 0
Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
Country 135392 0
Australia
Phone 135392 0
+61 4 1372 1939
Fax 135392 0
Email 135392 0
ali.fathi@tetratherix.com

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.