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

NCT06600152 | Active Not Recruiting DMC FDA Device

• 1 other identifier: TT-CLN-004-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse device effects in the treatment group compared to the control group.

  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.

  Week 0 (treatment) up to Week 24 (End of Study)

Study Arms (2)

Microporous Annealed Particle (MAP) Wound Matrix

EXPERIMENTAL

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

Device: MAP Wound Matrix

Hydrocolloid dressing (DuoDerm)

ACTIVE COMPARATOR

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

Device: DuoDerm

Interventions

MAP Wound Matrix DEVICE

The MAP Wound Matrix is indicated for the management of full thickness wounds, including surgical sites, donor skin graft sites, wound dehiscence, lacerations, and draining wounds. The application of MAP Wound Matrix will occur immediately after Mohs surgery once hemostasis has been achieved

Microporous Annealed Particle (MAP) Wound Matrix

DuoDerm DEVICE

DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer\'s instructions.

Hydrocolloid dressing (DuoDerm)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tempo Therapeutics: lead

Study Sites (3)

Cal Coast Dermatology

Encino, California, 91436, United States

Location

Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Studies in Dermatology

Cypress, Texas, 77429, United States

Location

MeSH Terms

Interventions

Bandages, Hydrocolloid

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Andrea Quach, BS

  Tempo Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization model.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)