Wound Heal
Conditions
Brief 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.
Interventions
DEVICEMAP Wound Matrix
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
DEVICEDuoDerm
DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer\'s instructions.
Sponsors
Tempo Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 randomization model.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group. | Week 0 (treatment) up to Week 24 (End of Study) | Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group. |
Countries
United States
Contacts
STUDY_DIRECTORAndrea Quach, BS
Tempo Therapeutics
Participant flow
Recruitment details
Participants were recruited at three U.S. dermatologic surgery centers. Eligible subjects were identified from patients scheduled to undergo Mohs micrographic surgery for non-melanoma skin cancer. Screening, informed consent, eligibility confirmation, and enrollment were conducted on the same day as surgery. Subjects were enrolled consecutively based on protocol-defined criteria. A total of 40 subjects were enrolled, within the planned enrollment range.
Pre-assignment details
All enrolled participants (N=40) were randomized and received the assigned intervention on the same day as enrollment. There were no exclusions between enrollment and assignment and no pre-assignment procedures (e.g., washout or run-in). No significant events occurred prior to assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 14 |
| other Total, other adverse events | 0 / 26 | 0 / 14 |
| serious Total, serious adverse events | 0 / 26 | 2 / 14 |
Outcome results
None listed