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

Joshua Choo

Status: Enrolling

Conditions: Wound Care; Trauma Wounds; Surgical Wound; Venous Ulcer; Pressure Ulcer; Draining Wound

Treatments: Device: Integra Dermal Regeneration template (IDRT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05311124

21.0937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Any full-thickness scalp wound extending to the cranium, devoid of pericranium that is:

1. 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.
2. 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

1. hypersensitivity of bovine collagen and/or chondroitin
2. previous treatment under same protocol
3. current or planned treatment/medication know to interfere with the rate and quality of wound healing.
4. suspected signs of wound infection
5. suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone
6. anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium
7. history of radiation to the field
8. history of other conditions/illness compromising the wound healing process (ESRD, immunosuppression),
9. absence of punctate cortical bleeding
10. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single-arm prospective

Experimental group

Description:

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

Treatment:

Device: Integra Dermal Regeneration template (IDRT)