NCT05311124

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

Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring: A Clinical and Histologic Study of Efficacy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Joshua Choo · Academic / Other
• Sex: All
• Age: 55 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with IDRT without burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.

Detailed description

Large full thickness scalp wounds often present a reconstructive challenge, as the size of the defect and the presence of denuded bone often preclude local flap options and skin grafting as methods of coverage. Integra dermal regeneration template (IDRT) has shown great utility in these types of wounds due to its ability to take in wounds with diminished vascularity, but the limits of this ability have not been determined. When used for full thickness scalp defects with exposed calvarium, for example, the accepted practice is that burring of the outer table to gain access to the vascularized diploic space is a necessary prerequisite step, although this is not always possible or desirable. The clinical question being investigated is whether healthy calvarium is sufficient for durable IDRT and subsequent skin graft take in wounds with a large surface area of denuded calvarium.

Conditions

• Wound Care
• Pressure Ulcer
• Venous Ulcer
• Surgical Wound
• Trauma Wounds
• Draining Wound

Interventions

Type	Name	Description
DEVICE	Integra Dermal Regeneration template (IDRT)	Integra Dermal Regeneration Template is a two-layer skin regeneration system. The outer layer is made of a thin silicone film that acts as your skin's epidermis. It protects the wound from infection and controls both heat and moisture loss. The inner layer is constructed of a complex matrix of cross-linked fibers. This porous material acts as a scaffold for regenerating dermal skin cells, which enables the re-growth of a functional dermal layer of skin. Once dermal skin has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-01
• Completion: 2023-10-01
• First posted: 2022-04-05
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study