Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring
NCT ID: NCT05311124
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2022-08-01
2023-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm prospective
Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
55 Years
100 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Joshua Choo
OTHER
Responsible Party
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Joshua Choo
Assistant Professor, M.D.
Principal Investigators
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Joshua H Choo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville School of Medicine Division of Plastic Surgery
Locations
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University of Louisville School of Medicine Division of Plastic Surgery
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Wright JK, Brawer MK. Survival of full-thickness skin grafts over avascular defects. Plast Reconstr Surg. 1980 Sep;66(3):428-32.
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.
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.
BROWN JB, CANNON B, et al. Further reports on the use of composite free grafts of skin and cartilage from the ear. Plast Reconstr Surg (1946). 1946 Sep;1:130-4. doi: 10.1097/00006534-194609000-00003. No abstract available.
BROWN JB, CANNON B. Composite free grafts of skin and cartilage from the ear. Surg Gynecol Obstet. 1946 Mar;82:253-5. No abstract available.
Hu YS. [Composite skin and cartilage free grafts from the ear for repair of partial nasal defects]. Zhonghua Wai Ke Za Zhi. 1983 Dec;21(12):746-7. No abstract available. Chinese.
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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.
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.
Muangman P, Engrav LH, Heimbach DM, Harunari N, Honari S, Gibran NS, Klein MB. Complex wound management utilizing an artificial dermal matrix. Ann Plast Surg. 2006 Aug;57(2):199-202. doi: 10.1097/01.sap.0000218636.61803.d6.
Baynosa RC, Browder LK, Jones SR, Oliver JA, Van Der Harten CA, Stephenson LL, Wang WZ, Khiabani KT, Zamboni WA. Evaluation of artificial dermis neovascularization in an avascular wound. J Reconstr Microsurg. 2009 Sep;25(7):405-10. doi: 10.1055/s-0029-1223848. Epub 2009 May 19.
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Other Identifiers
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21.0937
Identifier Type: -
Identifier Source: org_study_id
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