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Trial Title:
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients with Clean Surgical Wounds.
NCT ID:
NCT06600152
Condition:
Wound Heal
Conditions: Official terms:
Wounds and Injuries
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
2:1 randomization model.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MAP Wound Matrix
Description:
The MAP Wound Matrix is indicated for the management of full thickness wounds, including
surgical sites, donor skin graft sites, wound dehiscence, lacerations, and draining
wounds. The application of MAP Wound Matrix will occur immediately after Mohs surgery
once hemostasis has been achieved
Arm group label:
Microporous Annealed Particle (MAP) Wound Matrix
Intervention type:
Device
Intervention name:
DuoDerm
Description:
DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately
following Mohs surgery according to the manufacturer's instructions.
Arm group label:
Hydrocolloid dressing (DuoDerm)
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.
Criteria for 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.
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cal Coast Dermatology
Address:
City:
Encino
Zip:
91436
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research Coordinator
Phone:
818-208-9204
Email:
ldufour@calcoastderm.com
Contact backup:
Last name:
Stephanie J Martin, MD
Facility:
Name:
Laser and Skin Surgery Center of Indiana
Address:
City:
Indianapolis
Zip:
46260
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research Coordinator
Phone:
317-660-4862
Email:
jzenor@thelassi.com
Contact backup:
Last name:
C. William Hanke, MD
Facility:
Name:
Studies in Dermatology
Address:
City:
Cypress
Zip:
77429
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research Manager
Phone:
281-377-6665
Email:
lgarcia@studiesindermatology.com
Contact backup:
Last name:
Jennifer Hau, MD
Start date:
August 26, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Tempo Therapeutics
Agency class:
Industry
Source:
Tempo Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06600152
