Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Wound Heal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DuoDerm | Device | — | UNRESOLVED |
| MAP Wound Matrix | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Microporous Annealed Particle (MAP) Wound Matrix
- description
- The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS).
- interventionNames
- Device: MAP Wound Matrix
- type
- ACTIVE_COMPARATOR
- label
- Hydrocolloid dressing (DuoDerm)
- description
- A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.
- interventionNames
- Device: DuoDerm
Primary outcomes (1)
- measure
- Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHau JT, Martin SJ, Roosa CA, Deshayes S, Hanke CW. Microporous Annealed Particle Wound Matrix for Post-Mohs Defects: A Randomized Controlled Multicenter First-In-Human Study. Dermatol Surg. 2026 Aug 11. doi: 10.1097/DSS.0000000000005306. Online ahead of print. PMID 42574233