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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pressure Ulcer, Venous Ulcer, Surgical Wound, Trauma Wounds, Draining Wound, Wound Care

Intervention / Treatment
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* Device: Integra Dermal Regeneration template (IDRT)


Participation Criteria
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Eligibility Criteria
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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: hypersensitivity of bovine collagen and/or chondroitin previous treatment under same protocol current or planned treatment/medication know to interfere with the rate and quality of wound healing. suspected signs of wound infection suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium history of radiation to the field history of other conditions/illness compromising the wound healing process (ESRD, immunosuppression), absence of punctate cortical bleeding prior surgeries that would be expected to impair wound healing or vascularity of the underlying bone(e.g. history of craniectomy/bone flap, history of scalp flap/VP shunt.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be a single-arm prospective pilot study. Target of 10 enrolled patients at one study site under Joshua Choo, MD. Enrollment duration is 10 months - 1 year. Patients will have follow-up for 6 months per each patient.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm prospective<br>Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent. | Device: Integra Dermal Regeneration template (IDRT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete closure | Time to complete closure (in days), as assessed by full re-epithelialization | 10 - 12 months for study | 
| Percentage of subjects with complete closure of defect | Percentage of subjects with complete closure of defect | 10 - 12 months for study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent overall skin graft take | Percentage of overall skin graft take across all wounds as assessed by computerized planimetry (measured at 3 months) | Follow-up of each patient is 6/months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft