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N/A N=40 Randomized Treatment

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

Wound Heal

Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jun 2026
Primary outcome: Primary: Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group. — 0; 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MAP Wound Matrix (Device); DuoDerm (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Tempo Therapeutics
Primary completion
Jul 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.
0; 0

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06600152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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