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

Pressure Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Draining Wound
• Pressure Ulcer
• Surgical Wound
• Trauma Wounds
• Ulcer
• Varicose Ulcer
• Venous Ulcer
• Wound Care
• Wounds and Injuries

• NCT number: NCT05311124
• Study type: Interventional
• Source: University of Louisville
• Contact: Joshua H. Choo, MD
• Phone: 281.513.6459
• Email: Joshua.choo@louisville.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Completion date: October 1, 2023