Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
NCT ID: NCT00366041
Last Updated: 2010-01-21
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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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2006-02-28
2009-12-31
Brief Summary
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In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.
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Detailed Description
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A primary siliconized dressing will cover the wound. Secondary dressing: dressing gauze impregnated with physiologic serum and/or sterile dried dressing gauze, the whole is maintained by a (slightly compressive) tubular or elastic bandage.
Thin skin meshed autograft will occur 14 to 21 days after dermal substrate cellularised LG002 or uncellularised LG002 grafting (time frame necessary for the site to vascularize).
Meshed autograft development must be identical in both symmetric areas, for one single patient.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Cellularised LG002
Cellularised LG002
Dermal substrate cellularised LG002 (10x10cm)
application depending on burn injury surface
UnCellularised LG002
UnCellularised LG002
Dermal substrate uncellularised LG002 (10x10 cm)
depending on burn injury surface
Interventions
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Dermal substrate cellularised LG002 (10x10cm)
application depending on burn injury surface
Dermal substrate uncellularised LG002 (10x10 cm)
depending on burn injury surface
Eligibility Criteria
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Inclusion Criteria
* Thermal burn on symmetrical areas allowing grafting of 4 contiguous dermal substrates (cellularised LG002 or uncellularised LG002) on each area
* The patient himself, or his legal representative, must give his informed consent in writing
Exclusion Criteria
* Metabolic disease
* Systemic infection or local burn infection
* Known allergy to collagen, streptomycin, Penicillin and/or bovine origine products
18 Years
75 Years
ALL
No
Sponsors
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Hôpital d'Instruction des Armées de Percy
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Laboratoires Genévrier
INDUSTRY
Responsible Party
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sponsor
Principal Investigators
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Christine DOSQUET, MD
Role: STUDY_CHAIR
Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553
Daniel WASSERMANN, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Cochin, Service des Brûlés
Locations
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Hôpital d' Instruction des Armées de Percy, Service des Brûlés
Clamart, , France
Hôpital Cochin, Service des Brûlés
Paris, , France
Countries
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References
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Berthod F, Saintigny G, Chretien F, Hayek D, Collombel C, Damour O. Optimization of thickness, pore size and mechanical properties of a biomaterial designed for deep burn coverage. Clin Mater. 1994;15(4):259-65. doi: 10.1016/0267-6605(94)90055-8.
Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6. doi: 10.1016/0267-6605(94)90057-4.
Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol. 1989 Jan;92(1):122-5. doi: 10.1111/1523-1747.ep13071335.
Berthod F, Hayek D, Damour O, Collombel C. Collagen synthesis by fibroblasts cultured within a collagen sponge. Biomaterials. 1993 Aug;14(10):749-54. doi: 10.1016/0142-9612(93)90039-5.
Froget S, Barthelemy E, Guillot F, Soler C, Coudert MC, Benbunan M, Dosquet C. Wound healing mediator production by human dermal fibroblasts grown within a collagen-GAG matrix for skin repair in humans. Eur Cytokine Netw. 2003 Jan-Mar;14(1):60-4.
Saintigny G, Bonnard M, Damour O, Collombel C. Reconstruction of epidermis on a chitosan cross-linked collagen-GAG lattice: effect of fibroblasts. Acta Derm Venereol. 1993 Jun;73(3):175-80. doi: 10.2340/0001555573175180.
Sher SE, Hull BE, Rosen S, Church D, Friedman L, Bell E. Acceptance of allogeneic fibroblasts in skin equivalent transplants. Transplantation. 1983 Nov;36(5):552-7. doi: 10.1097/00007890-198311000-00015.
Braye FM, Stefani A, Venet E, Pieptu D, Tissot E, Damour O. Grafting of large pieces of human reconstructed skin in a porcine model. Br J Plast Surg. 2001 Sep;54(6):532-8. doi: 10.1054/bjps.2001.3620.
Coulomb B, Friteau L, Baruch J, Guilbaud J, Chretien-Marquet B, Glicenstein J, Lebreton-Decoster C, Bell E, Dubertret L. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Plast Reconstr Surg. 1998 Jun;101(7):1891-903. doi: 10.1097/00006534-199806000-00018.
Other Identifiers
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03F/DE01
Identifier Type: -
Identifier Source: org_study_id
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