N/A
N=40
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
Wound Heal
Bottom Line
View on ClinicalTrials.gov: NCT06600152 ↗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
| Outcome | Result | p-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.
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.