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

October 17, 2022 updated by: Joshua Choo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville School of Medicine Division of Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Joshua H. Choo, MD
        • Sub-Investigator:
          • Bradon J. Wilhelmi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm prospective
Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete closure
Time Frame: 10 - 12 months for study
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
Time Frame: 10 - 12 months for study
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
Time Frame: Follow-up of each patient is 6/months.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin graft stability
Time Frame: Within a 6/month follow-up period
Skin graft stability as assessed by percentage skin graft take (measured at 6 months)
Within a 6/month follow-up period
Histologic appearance of wounds treated with Integra immediately prior to skin graft
Time Frame: During study follow-up of 6/months
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
Assessment of neodermis formation
Time Frame: During study follow-up of 6/months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Choo

Collaborators

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: Joshua H Choo, MD, University of Louisville School of Medicine Division of Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.0937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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