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

Last updated: September 30, 2024
Sponsor: Tempo Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DuoDerm

MAP Wound Matrix

Clinical Study ID

NCT06600152
TT-CLN-004-03
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to undergo the written informed consent process prior to enrollment in thisstudy.

  • At least 22 years of age at screening.

  • Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohsmicrographic surgery on a location suitable for secondary intention healing.

  • Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm andno 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

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 anappropriate form of birth control (adequate birth control methods are defined as:topical, oral, implantable, or injectable contraceptives; spermicide in conjunctionwith a barrier such as a condom or diaphragm; IUD; or surgical sterilization ofpartner).

  • Has clinical evidence of Peripheral Vascular Disease (PVD) in the form of grade 2pitting 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 thetrial.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: DuoDerm
Phase:
Study Start date:
August 26, 2024
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Cal Coast Dermatology

    Encino, California 91436
    United States

    Active - Recruiting

  • Laser and Skin Surgery Center of Indiana

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Studies in Dermatology

    Cypress, Texas 77429
    United States

    Active - Recruiting

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