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

Tempo Therapeutics

Status: Enrolling

Conditions: Wound Heal

Treatments: Device: MAP Wound Matrix; Device: DuoDerm

Study type: Interventional

Funder types: Industry

Identifiers

NCT06600152

TT-CLN-004-03

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

_ 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Microporous Annealed Particle (MAP) Wound Matrix

Experimental group

Description:

The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS).

Treatment:

Device: MAP Wound Matrix

Hydrocolloid dressing (DuoDerm)

Active Comparator group

Description:

A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.

Treatment:

Device: DuoDerm