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Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients with Clean Surgical Wounds. (MOSAIC Trial)
N/A
Recruiting
Research Sponsored by Tempo Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (treatment) up to week 24 (end of study)
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Wound Healing
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 (treatment) up to week 24 (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (treatment) up to week 24 (end of study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of serious adverse device effects in the treatment group compared to the control group.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Microporous Annealed Particle (MAP) Wound MatrixExperimental Treatment1 Intervention
The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS).
Group II: Hydrocolloid dressing (DuoDerm)Active Control1 Intervention
A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.
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Who is running the clinical trial?
Tempo TherapeuticsLead Sponsor
Andrea Quach, BSStudy DirectorTempo Therapeutics