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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
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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
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Secondary ID [1]
312475
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TD-SR-001
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Universal Trial Number (UTN)
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Trial acronym
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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.
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Health condition
Health condition(s) or problem(s) studied:
Scar Management
334505
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Condition category
Condition code
Surgery
331119
331119
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0
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Other surgery
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Skin
331120
331120
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
329100
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Treatment: Devices
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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,
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Primary outcome [2]
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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.
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Assessment method [2]
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Clinical Observations at baseline
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Timepoint [2]
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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)
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Secondary outcome [1]
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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.
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Assessment method [1]
437885
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Vancouver Scar Scale (VSS)
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Timepoint [1]
437885
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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
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Secondary outcome [2]
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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.
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Assessment method [2]
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Clinical Photography
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Timepoint [2]
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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)
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Secure password protected randomisation schedule
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/09/2024
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Actual
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Date of last participant enrolment
Anticipated
10/07/2025
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Actual
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Date of last data collection
Anticipated
10/07/2026
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Actual
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Sample size
Target
45
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
316893
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Commercial sector/Industry
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Name [1]
316893
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Tetratherix Technology Pty Ltd
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Address [1]
316893
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Country [1]
316893
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Tetratherix Technology Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
319143
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None
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Name [1]
319143
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Address [1]
319143
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Country [1]
319143
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315655
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St Vincent’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
315655
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https://svhs.org.au/home/research-education/research-office
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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09/04/2024
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Approval date [1]
315655
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26/04/2024
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Ethics approval number [1]
315655
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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 a 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. There is a seperate ANZCTR application for cohort 1, this is the application for cohort 2 and 3. Up to 45 participants will be enrolled in cohorts 2 and 3 in Australia. There will be a total of 11 subject visits occurring over 12 months.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Drew Cronin
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Address
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The Coastal Clinic Plastic Surgery & Aesthetics Suite 5.2B, Level 5, 123 Nerang Street, Southport QLD 4215
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Country
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Australia
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Phone
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+61 07 5683 4215
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ali Fathi
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Address
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Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
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Country
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Australia
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Phone
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+61 4 1372 1939
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Fax
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Email
135391
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[email protected]
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Contact person for scientific queries
Name
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Ali Fathi
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Address
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Tetratherix Technology Pty Ltd, Suite 5301, Level 53, 19-29 Martin Place, Sydney NSW 2000
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Country
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Australia
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Phone
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+61 4 1372 1939
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Fax
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Email
135392
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Patient and company confidentiality
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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.
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