Status:
ACTIVE_NOT_RECRUITING
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
Lead Sponsor:
Tempo Therapeutics
Conditions:
Wound Heal
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after sk...
Eligibility Criteria
Inclusion
- Willing to undergo the written informed consent process prior to enrollment in this study.
- At least 22 years of age at screening.
- Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohs micrographic surgery on a location suitable for secondary intention healing.
- Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm and no more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2).
- Resulting surgical wound after Mohs micrographic surgery must be full thickness.
- Willing to return for all required follow-up visits.
- Willing to follow the instructions of the Principal Investigator.
Exclusion
- \_ Has a confirmed diagnosis of clinically significant peripheral neuropathy.
- Has uncontrolled Type I or Type II diabetes and HbA1c values greater than 8.0% within the last 6 months.
- Has a known infection in the area of the Mohs micrographic surgery.
- Has a known allergy to any of the components of the TT101 Device.
- Is an active daily cigarette smoker.
- Is pregnant or lactating.
- Is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner).
- Has clinical evidence of Peripheral Vascular Disease (PVD) in the form of grade 2 pitting Edema or higher.
- Has been diagnosed with a surgical or wound site infection within the last 6-months.
- Has been diagnosed with chronic ulcer or wound within the last 12- months.
- Has a remote active infection concurrent with having the Mohs micrographic surgery.
- Per Investigator's discretion the subject is not appropriate for inclusion in the trial.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06600152
Start Date
August 26 2024
End Date
August 30 2026
Last Update
August 11 2025
Active Locations (3)
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1
Cal Coast Dermatology
Encino, California, United States, 91436
2
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, United States, 46260
3
Studies in Dermatology
Cypress, Texas, United States, 77429