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Wound CareNCT05311124

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

A study testing Integra Dermal Regeneration template (IDRT) in people with Wound Care and Pressure Ulcer, run by Joshua Choo at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 55 to 100 years
Conditions the study is for
Wound Care, Pressure Ulcer, Venous Ulcer
What is being tested?
Integra Dermal Regeneration template (IDRT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Joshua H. Choo, MD contact

281.513.6459

Joshua.choo@louisville.edu

Bradon J. Wilhelmi, MD contact

502.689.4143

Bradon.wilhelmi@louisville.edu

United States1 site, 1 recruiting

  • University of Louisville School of Medicine Division of Plastic Surgery

    Louisville, Kentucky, 40202

    Helen L. Anderkin, BS, 502-588-4543, Helen.andrekin@louisville.edu

    Joshua H. Choo, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Integra Dermal Regeneration template (IDRT)
Keywords
Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft
Medical subject headings
Pressure Ulcer, Varicose Ulcer, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integra Dermal Regeneration template (IDRT)Device

    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.

Study groups in NCT05311124
Study groupRoleWhat they receive
Single-arm prospectiveExperimentalSingle-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.
Receives: Device: Integra Dermal Regeneration template (IDRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to complete closure

    Time to complete closure (in days), as assessed by full re-epithelialization

    Measured: 10 - 12 months for study

  2. Percentage of subjects with complete closure of defect

    Percentage of subjects with complete closure of defect

    Measured: 10 - 12 months for study

Secondary outcomes (1)

  1. Percent overall skin graft take

    Percentage of overall skin graft take across all wounds as assessed by computerized planimetry (measured at 3 months)

    Measured: Follow-up of each patient is 6/months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05311124
Sponsor's protocol ID
21.0937
Status last verified
Oct 2022
First submitted
11 Mar 2022
Last updated
18 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Magnoni C, De Santis G, Fraccalvieri M, Bellini P, Portincasa A, Giacomelli L, Papa G. Integra in Scalp Reconstruction After Tumor Excision: Recommendations From a Multidisciplinary Advisory Board. J Craniofac Surg. 2019 Nov-Dec;30(8):2416-2420. doi: 10.1097/SCS.0000000000005717.

    PubMed 31274819

  • Gonyon DL Jr, Zenn MR. Simple approach to the radiated scalp wound using INTEGRA skin substitute. Ann Plast Surg. 2003 Mar;50(3):315-20. doi: 10.1097/01.sap.0000046788.45508.a3.

    PubMed 12800912

  • Yeong EK, Huang HF, Chen YB, Chen MT. The use of artificial dermis for reconstruction of full thickness scalp burn involving the calvaria. Burns. 2006 May;32(3):375-9. doi: 10.1016/j.burns.2005.08.015.

    PubMed 16546668

  • Komorowska-Timek E, Gabriel A, Bennett DC, Miles D, Garberoglio C, Cheng C, Gupta S. Artificial dermis as an alternative for coverage of complex scalp defects following excision of malignant tumors. Plast Reconstr Surg. 2005 Apr;115(4):1010-7. doi: 10.1097/01.prs.0000154210.60284.c6.

    PubMed 15793438

  • Muhlstadt M, Thome C, Kunte C. Rapid wound healing of scalp wounds devoid of periosteum with milling of the outer table and split-thickness skin grafting. Br J Dermatol. 2012 Aug;167(2):343-7. doi: 10.1111/j.1365-2133.2012.10999.x. Epub 2012 Jul 5.

    PubMed 22512740

  • Jeyaraj P. Split Calvarial Grafting for Closure of Large Cranial Defects: The Ideal Option? J Maxillofac Oral Surg. 2019 Dec;18(4):518-530. doi: 10.1007/s12663-019-01198-w. Epub 2019 Feb 9.

    PubMed 31624429

  • Haybaeck J, Silye R, Soffer D. Dural arachnoid granulations and "giant" arachnoid granulations. Surg Radiol Anat. 2008 Jul;30(5):417-21. doi: 10.1007/s00276-008-0345-2. Epub 2008 Apr 8.

    PubMed 18392764

  • Bernstein JL, Premaratne ID, Levy AS, Kuhel WI, Kutler DI, Spector JA. Reconstruction of Full Thickness Scalp Defects in Extremely Elderly Patients Using Dermal Regeneration Templates. J Craniofac Surg. 2020 Jul-Aug;31(5):e511-e514. doi: 10.1097/SCS.0000000000006646.

    PubMed 32541269

  • Yannas IV, Orgill DP, Burke JF. Template for skin regeneration. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:60S-70S. doi: 10.1097/PRS.0b013e318200a44d.

    PubMed 21200274

  • Yannas IV, Burke JF, Orgill DP, Skrabut EM. Wound tissue can utilize a polymeric template to synthesize a functional extension of skin. Science. 1982 Jan 8;215(4529):174-6. doi: 10.1126/science.7031899.

    PubMed 7031899

  • Yannas IV, Lee E, Orgill DP, Skrabut EM, Murphy GF. Synthesis and characterization of a model extracellular matrix that induces partial regeneration of adult mammalian skin. Proc Natl Acad Sci U S A. 1989 Feb;86(3):933-7. doi: 10.1073/pnas.86.3.933.

    PubMed 2915988

  • Helgeson MD, Potter BK, Evans KN, Shawen SB. Bioartificial dermal substitute: a preliminary report on its use for the management of complex combat-related soft tissue wounds. J Orthop Trauma. 2007 Jul;21(6):394-9. doi: 10.1097/BOT.0b013e318070c028.

    PubMed 17620998

  • Lee LF, Porch JV, Spenler W, Garner WL. Integra in lower extremity reconstruction after burn injury. Plast Reconstr Surg. 2008 Apr;121(4):1256-1262. doi: 10.1097/01.prs.0000304237.54236.66.

    PubMed 18349644

  • Shores JT, Hiersche M, Gabriel A, Gupta S. Tendon coverage using an artificial skin substitute. J Plast Reconstr Aesthet Surg. 2012 Nov;65(11):1544-50. doi: 10.1016/j.bjps.2012.05.021. Epub 2012 Jun 20.

    PubMed 22721977

  • Jeng JC, Fidler PE, Sokolich JC, Jaskille AD, Khan S, White PM, Street JH 3rd, Light TD, Jordan MH. Seven years' experience with Integra as a reconstructive tool. J Burn Care Res. 2007 Jan-Feb;28(1):120-6. doi: 10.1097/BCR.0b013E31802CB83F.

    PubMed 17211211

Questions about this trial

What is this clinical trial studying?

A study testing Integra Dermal Regeneration template (IDRT) in people with Wound Care and Pressure Ulcer, run by Joshua Choo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joshua H. Choo, MD (281.513.6459, Joshua.choo@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to complete closure (time frame: 10 - 12 months for study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311124, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.

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