Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring

Overseen by Joshua H Choo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Joshua Choo

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if a special artificial skin (IDRT) can help heal large, deep scalp wounds that expose the skull bone without needing extra steps to prepare the bone. It aims to see if this method can work reliably for these difficult-to-treat wounds.

Research Team

Joshua H Choo, MD

Principal Investigator

University of Louisville School of Medicine Division of Plastic Surgery

Eligibility Criteria

Inclusion Criteria

Any full-thickness scalp wound extending to the cranium, devoid of pericranium that is: greater than or equal to 2 cm and/or is deemed by the treating physician not to be amenable to closure by simple means, primary closure or local flap.

occurring in as elder patient > 55 years old with co-morbid conditions that constitute and anesthetic risk (ASA) >=3 that demonstrates punctate bleeding from healthy appearing cortical bone following debridement/extirpation

Exclusion Criteria

You have a condition called osteomyelitis or osteoradionecrosis, or your bones don't have enough strength to support the implant.

You have a medical history that could slow down the healing process of wounds or injuries, such as kidney disease or taking medicines that weaken your immune system.

previous treatment under same protocol

Treatment Details

Interventions

• Integra Dermal Regeneration Template (IDRT) (Dermal Regeneration Template)

Participant Groups

Group I: Single-arm prospective Experimental Treatment 1 Intervention

Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.

Who Is Running the Clinical Trial?

Joshua Choo

Lead Sponsor

Trials

1

Recruited

10+

Integra LifeSciences Corporation

Industry Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School