Evaluating a new wound healing device for surgical wounds after skin cancer surgery.
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.
This study is testing a new wound healing device to see if it helps people heal better after skin cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Tempo Therapeutics Industry-sponsored |
| Locations | 3 sites (Encino, California and 2 other locations) |
| Trial ID | NCT06600152 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of the Microporous Annealed Particle (MAP) Wound Matrix, a volumetric biomaterial scaffold, in patients undergoing Mohs micrographic surgery for non-melanoma skin cancer. Participants will be randomly assigned to receive either the MAP Wound Matrix or a control treatment, with the aim of assessing the effectiveness of the device in promoting wound healing. The study will involve follow-up visits to monitor healing progress and any potential adverse effects associated with the device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with non-melanoma skin cancer scheduled for Mohs micrographic surgery resulting in a clean surgical wound suitable for secondary intention healing.
Not a fit: Patients with significant peripheral neuropathy, uncontrolled diabetes, or infections in the surgical area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for improving wound healing in patients after skin cancer surgery.
How similar studies have performed: While the specific MAP Wound Matrix approach is novel, similar studies evaluating biomaterial scaffolds for wound healing have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Encino, California and 2 other locations
- Cal Coast Dermatology — Encino, California, United States (Recruiting)
- Laser and Skin Surgery Center of Indiana — Indianapolis, Indiana, United States (Recruiting)
- Studies in Dermatology — Cypress, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Andrea Quach, BS
- Email: andrea.quach@tempothera.com
- Phone: 4088022787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.