Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds. (NCT06600152) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
United States40 participantsStarted 2024-08-26
Plain-language 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.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Vascula…
What they're measuring
1
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)