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

Primary Purpose

Wound Care, Pressure Ulcer, Venous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integra Dermal Regeneration template (IDRT)
Sponsored by
Joshua Choo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Care focused on measuring Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Louisville School of Medicine Division of Plastic SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm prospective

Arm Description

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

Outcomes

Primary Outcome Measures

Time to complete closure
Time to complete closure (in days), as assessed by full re-epithelialization
Percentage of subjects with complete closure of defect
Percentage of subjects with complete closure of defect

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2022
Last Updated
October 17, 2022
Sponsor
Joshua Choo
Collaborators
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05311124
Brief Title
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring
Official Title
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring: A Clinical and Histologic Study of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Choo
Collaborators
Integra LifeSciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Care, Pressure Ulcer, Venous Ulcer, Surgical Wound, Trauma Wounds, Draining Wound
Keywords
Interga Dermal Regeneration Template (IDRT), Bare Calvarium, scalp wounds, skin graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
The study design is a single-arm prospective pilot study with all patient receiving the IDRT wound care device.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-arm prospective
Arm Type
Experimental
Arm Description
Single-arm prospective pilot study. All patients receive Integra dermal regeneration template (IDRT) that sign an inform consent.
Intervention Type
Device
Intervention Name(s)
Integra Dermal Regeneration template (IDRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to complete closure
Description
Time to complete closure (in days), as assessed by full re-epithelialization
Time Frame
10 - 12 months for study
Title
Percentage of subjects with complete closure of defect
Description
Percentage of subjects with complete closure of defect
Time Frame
10 - 12 months for study
Secondary Outcome Measure Information:
Title
Percent overall skin graft take
Description
Percentage of overall skin graft take across all wounds as assessed by computerized planimetry (measured at 3 months)
Time Frame
Follow-up of each patient is 6/months.
Other Pre-specified Outcome Measures:
Title
Skin graft stability
Description
Skin graft stability as assessed by percentage skin graft take (measured at 6 months)
Time Frame
Within a 6/month follow-up period
Title
Histologic appearance of wounds treated with Integra immediately prior to skin graft
Description
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.
Time Frame
During study follow-up of 6/months
Title
Assessment of neodermis formation
Description
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.
Time Frame
During study follow-up of 6/months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua H. Choo, MD
Phone
281.513.6459
Email
Joshua.choo@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bradon J. Wilhelmi, MD
Phone
502.689.4143
Email
Bradon.wilhelmi@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua H Choo, MD
Organizational Affiliation
University of Louisville School of Medicine Division of Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville School of Medicine Division of Plastic Surgery
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen L. Anderkin, BS
Phone
502-588-4543
Email
Helen.andrekin@louisville.edu
First Name & Middle Initial & Last Name & Degree
Joshua H. Choo, MD
First Name & Middle Initial & Last Name & Degree
Bradon J. Wilhelmi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31274819
Citation
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.
Results Reference
background
PubMed Identifier
12800912
Citation
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.
Results Reference
background
PubMed Identifier
16546668
Citation
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.
Results Reference
background
PubMed Identifier
15793438
Citation
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.
Results Reference
background
PubMed Identifier
22512740
Citation
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.
Results Reference
background
PubMed Identifier
31624429
Citation
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.
Results Reference
background
PubMed Identifier
18392764
Citation
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.
Results Reference
background
PubMed Identifier
32541269
Citation
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.
Results Reference
background
PubMed Identifier
21200274
Citation
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.
Results Reference
background
PubMed Identifier
7031899
Citation
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.
Results Reference
background
PubMed Identifier
2915988
Citation
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.
Results Reference
background
PubMed Identifier
17620998
Citation
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.
Results Reference
background
PubMed Identifier
18349644
Citation
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.
Results Reference
background
PubMed Identifier
22721977
Citation
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.
Results Reference
background
PubMed Identifier
17211211
Citation
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.
Results Reference
background
PubMed Identifier
23970464
Citation
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.
Results Reference
background
PubMed Identifier
20595857
Citation
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.
Results Reference
background
PubMed Identifier
6999514
Citation
Wright JK, Brawer MK. Survival of full-thickness skin grafts over avascular defects. Plast Reconstr Surg. 1980 Sep;66(3):428-32.
Results Reference
background
PubMed Identifier
16042930
Citation
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.
Results Reference
background
PubMed Identifier
20253943
Citation
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.
Results Reference
background
PubMed Identifier
21000871
Citation
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.
Results Reference
background
PubMed Identifier
21014134
Citation
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.
Results Reference
background
PubMed Identifier
6676033
Citation
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.
Results Reference
background
PubMed Identifier
1089983
Citation
Gingrass P, Grabb WC, Gingrass RP. Skin graft survival on avascular defects. Plast Reconstr Surg. 1975 Jan;55(1):65-70. doi: 10.1097/00006534-197501000-00010.
Results Reference
background
PubMed Identifier
25414619
Citation
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.
Results Reference
background
PubMed Identifier
16799385
Citation
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.
Results Reference
background
PubMed Identifier
16862003
Citation
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.
Results Reference
background
PubMed Identifier
19455489
Citation
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.
Results Reference
background
PubMed Identifier
16093952
Citation
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.
Results Reference
background
PubMed Identifier
1642769
Citation
Bizhko IP, Slesarenko SV. Operative treatment of deep burns of the scalp and skull. Burns. 1992 Jun;18(3):220-3. doi: 10.1016/0305-4179(92)90073-4.
Results Reference
background

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

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