ACTRN12624000965505
Recruiting
N/A
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
Tetratherix Technology Pty Ltd0 sites45 target enrollmentAugust 8, 2024
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Scar Management
- Sponsor
- Tetratherix Technology Pty Ltd
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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