Clinical trial NCT06600152: Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients with Clean Surgical Wounds.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Heal
Lead sponsor: Tempo Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization model.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of serious adverse device effects in the treatment group compared to the control group.
timeFrame: Week 0 (treatment) up to Week 24 (End of Study)
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Cal Coast Dermatology
state: California
city: Indianapolis
country: United States
facility: Laser and Skin Surgery Center of Indiana
state: Indiana
city: Cypress
country: United States
facility: Studies in Dermatology
state: Texas
Study officials:
affiliation: Tempo Therapeutics
name: Andrea Quach, BS
role: STUDY_DIRECTOR
References: