None listed
Conditions
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.
Interventions
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 ope
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)
Sponsors
Tetratherix Technology Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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
Outcome results
None listed