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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311124
• Other study ID #: 21.0937
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2022
• Source: University of Louisville
• Contact: Joshua H. Choo, MD
• Phone: 281.513.6459
• Email: Joshua.choo[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville School of Medicine Division of Plastic Surgery	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Joshua Choo	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin graft stability	Skin graft stability as assessed by percentage skin graft take (measured at 6 months)	Within a 6/month follow-up period
Other	Histologic appearance of wounds treated with Integra immediately prior to skin graft	Comparison of vascular ingrowth (measured by number of CD31 staining cells/hpf) and fibroblast infiltration (measured by density of anti-vimentin staining/hpf) at the periphery and center of provisional matrix immediately prior to skin graft in each reconstructed wound.	During study follow-up of 6/months
Other	Assessment of neodermis formation	Qualitative histologic analysis of tissue samples for presence of recognizable epidermis, dermis, rete-ridges and collagen organization resembling normal skin as assessed by independent pathologist's review at center and periphery of final reconstruction.	During study follow-up of 6/months.
Primary	Time to complete closure	Time to complete closure (in days), as assessed by full re-epithelialization	10 - 12 months for study
Primary	Percentage of subjects with complete closure of defect	Percentage of subjects with complete closure of defect	10 - 12 months for study
Secondary	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.