[Trial of device that is not approved or cleared by the U.S. FDA]

Not Applicable

Recruiting

• Conditions: Wound Heal
• Interventions: Device: MAP Wound Matrix; Device: DuoDerm

• Registration Number: NCT06600152
• Lead Sponsor: [Redacted]

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-26
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microporous Annealed Particle (MAP) Wound Matrix	MAP Wound Matrix	The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS).
Hydrocolloid dressing (DuoDerm)	DuoDerm	A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse device effects in the treatment group compared to the control group.	Week 0 (treatment) up to Week 24 (End of Study)	Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.

Trial Locations

Locations (3)

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