Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.

Completed · Not applicable

Conditions studied: Wound Heal

In brief

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 skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.

Key facts

Study ID

NCT06600152

Run by

Tempo Therapeutics

People needed

40

Starts

2024-08-26

Expected to finish

2025-07-30

Last updated by the study team

2026-06-03

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• _ 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.

Where it is running

• Cal Coast Dermatology — Encino, California, United States
• Laser and Skin Surgery Center of Indiana — Indianapolis, Indiana, United States
• Studies in Dermatology — Cypress, Texas, United States

Full record on ClinicalTrials.gov

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