ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-08-26

Study Completion:2026-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06600152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Andrea Quach, BS

STUDY_DIRECTOR

Tempo Therapeutics

Study Locations (Sites)

Cal Coast Dermatology

Encino, California, 91436

United States

Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260

United States

Studies in Dermatology

Cypress, Texas, 77429

United States

Collaborators and Investigators

Sponsor: Tempo Therapeutics

Andrea Quach, BS, STUDY_DIRECTOR, Tempo Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26

Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-08-26

Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

Wound Heal