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OpenTrials
Completed

NCT Number: NCT06600152

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

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.

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Key information

Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cal Coast Dermatology, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

DuoDerm

Device

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

Primary outcomes

  1. Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tempo Therapeutics

Industry

Registry information

Official study 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.

Acronym: MOSAIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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