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

NCT05311124 | Unknown DMC FDA Device

• 1 other identifier: 21.0937
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percent overall skin graft take

  Follow-up of each patient is 6/months.

Other Outcomes (3)

• Skin graft stability

  Within a 6/month follow-up period

• Histologic appearance of wounds treated with Integra immediately prior to skin graft

  During study follow-up of 6/months

• Assessment of neodermis formation

  During study follow-up of 6/months.

Study Arms (1)

Single-arm prospective

EXPERIMENTAL

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

Device: Integra Dermal Regeneration template (IDRT)

Interventions

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.

Single-arm prospective

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joshua Choo: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

University of Louisville School of Medicine Division of Plastic Surgery

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (30)

• 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.

  PMID: 31274819 BACKGROUND

• 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.

  PMID: 12800912 BACKGROUND

• 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.

  PMID: 16546668 BACKGROUND

• 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.

  PMID: 15793438 BACKGROUND

• 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.

  PMID: 22512740 BACKGROUND

• 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.

  PMID: 31624429 BACKGROUND

• 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.

  PMID: 18392764 BACKGROUND

• 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.

  PMID: 32541269 BACKGROUND

• 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.

  PMID: 21200274 BACKGROUND

• 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.

  PMID: 7031899 BACKGROUND

• 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.

  PMID: 2915988 BACKGROUND

• 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.

  PMID: 17620998 BACKGROUND

• 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.

  PMID: 18349644 BACKGROUND

• 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.

  PMID: 22721977 BACKGROUND

• 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.

  PMID: 17211211 BACKGROUND

• van Wingerden JJ, Lapid O, van der Horst CM. Bridging phenomenon - Simplifying complex ear reconstructions. Head Neck. 2014 May;36(5):735-8. doi: 10.1002/hed.23458. Epub 2013 Nov 7.

  PMID: 23970464 BACKGROUND

• Lindenblatt N, Platz U, Althaus M, Hegland N, Schmidt CA, Contaldo C, Vollmar B, Giovanoli P, Calcagni M. Temporary angiogenic transformation of the skin graft vasculature after reperfusion. Plast Reconstr Surg. 2010 Jul;126(1):61-70. doi: 10.1097/PRS.0b013e3181da87f6.

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  PMID: 6999514 BACKGROUND

• Adams DC, Ramsey ML. Grafts in dermatologic surgery: review and update on full- and split-thickness skin grafts, free cartilage grafts, and composite grafts. Dermatol Surg. 2005 Aug;31(8 Pt 2):1055-67. doi: 10.1111/j.1524-4725.2005.31831.

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• BROWN JB, CANNON B, et al. Composite free grafts of skin and cartilage from the ear. J Am Med Assoc. 1947 Aug 16;134(16):1295. doi: 10.1001/jama.1947.02880330017006. No abstract available.

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• Hulsen J, Diederich R, Neumeister MW, Bueno RA Jr. Integra(R) dermal regenerative template application on exposed tendon. Hand (N Y). 2014 Dec;9(4):539-42. doi: 10.1007/s11552-014-9630-1.

  PMID: 25414619 BACKGROUND

• Moiemen NS, Vlachou E, Staiano JJ, Thawy Y, Frame JD. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):160S-174S. doi: 10.1097/01.prs.0000222609.40461.68.

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• Violas P, Abid A, Darodes P, Galinier P, de Gauzy JS, Cahuzac JP. Integra artificial skin in the management of severe tissue defects, including bone exposure, in injured children. J Pediatr Orthop B. 2005 Sep;14(5):381-4. doi: 10.1097/01202412-200509000-00013.

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MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Wounds and Injuries

Study Officials

• Joshua H Choo, MD

  University of Louisville School of Medicine Division of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua H. Choo, MD

CONTACT

281.513.6459; Joshua.choo@louisville.edu

Bradon J. Wilhelmi, MD

CONTACT

502.689.4143; Bradon.wilhelmi@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study design is a single-arm prospective pilot study with all patient receiving the IDRT wound care device.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, M.D.

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 5, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

US (1)