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

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.

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 Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: MAP Wound Matrix; Device: DuoDerm

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Cal Coast Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Laser and Skin Surgery Center of Indiana
  • Texas
    • Cypress, Texas, United States, 77429
      • Studies in Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microporous Annealed Particle (MAP) Wound Matrix; 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; 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
Active Comparator: Hydrocolloid dressing (DuoDerm); A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.	Device: DuoDerm; DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer's instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Tempo Therapeutics
• Investigators: Study Director: Andrea Quach, BS, Tempo Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Equipment and Supplies; Bandages; Bandages, Hydrocolloid
• Other Study ID Numbers: TT-CLN-004-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No