Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries - Full Text View

Sponsors and Collaborators:	Laboratoires Genévrier Hôpital d'Instruction des Armées de Percy Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Laboratoires Genévrier
ClinicalTrials.gov Identifier:	NCT00366041

Purpose

After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

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.

Condition	Intervention	Phase
Burns	Drug: Dermal substrate cellularised LG002 (10x10cm) Device: Dermal substrate uncellularised LG002 (10x10 cm)	Phase II

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicentre Clinical Study to Compare the Efficacy and the Tolerance of Cellularised LG002 With the Efficacy and Tolerance of Uncellularised LG002 in the Treatment of Severe Burn Injury

Further study details as provided by Laboratoires Genévrier:

Primary Outcome Measures:

Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)

Secondary Outcome Measures:

Short and medium term: Percentage of take of thin skin autografts 12 and 30 days after their application
Long term: Clinical evaluation (Vancouver scale 1, 3, 6, 12 months) and histological evaluation (3mm biopsy) to investigate the dermal-epidermal junction and the extra-cellular matrix (1 and 6 month) in order to evaluate the scar quality
Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance
Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)

Estimated Enrollment:	20
Study Start Date:	February 2006
Estimated Study Completion Date:	September 2008

Detailed Description:

For lesions that cannot heal spontaneously, the wound is excised until fascia. Four contiguous dermal substrates (uncellularised and cellularised) are randomly grafted on each symmetric area.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with severe burn injuries ≥ 40 % of TBSA (Total Body Surface Area)
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:

Anterior progressive serious illness (i.e severe hepatic insufficiency, immunodepression induced by corticotherapy or illness (AIDS))
Metabolic disease
Systemic infection or local burn infection
Known allergy to collagen, streptomycin, Penicillin and/or bovine origine products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366041

Contacts

Contact: Carole Robin, PharmD

+ 33 4 92914973

crobin@laboratoires-genevrier.com

Locations

France
Hôpital d' Instruction des Armées de Percy, Service des Brûlés	Recruiting
Clamart, France, 92141
Contact: Hervé CARSIN, MD + 33 1 41 46 62 11 carsin.herve@wanadoo.fr
Contact: Eric BEY, MD +33 1 41 46 62 02 bey.percy@yahoo.fr
Principal Investigator: Hervé CARSIN, MD
Sub-Investigator: BARGUES, MD
Sub-Investigator: MORELL, MD
Sub-Investigator: Eric BEY, MD
Sub-Investigator: Nicolas TEYSSERES, MD
Sub-Investigator: Anne LAKHEL-LE-COADOU, MD
Sub-Investigator: Patrick DUHAMEL, MD
Hôpital Cochin, Service des Brûlés	Recruiting
Paris, France, 75679
Contact: Daniel WASSERMANN, MD +33 1 58 41 26 56 daniel.wassermann@cch.ap-hop-paris.fr
Principal Investigator: Daniel WASSERMANN, MD
Sub-Investigator: Mourad BENYAMINA, MD
Sub-Investigator: Christophe VINSONNEAU, MD
Sub-Investigator: Caroline AUGRIS-MATHIEU, MD
Sub-Investigator: Sonia GAUCHER, MD
Sub-Investigator: Jean STEPHANAZZI, MD

Sponsors and Collaborators

Laboratoires Genévrier

Hôpital d'Instruction des Armées de Percy

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Study Chair:	Christine DOSQUET, MD	Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553
Principal Investigator:	Hervé CARSIN, MD	Hôpital d'Instruction des Armées de Percy, Service des Brûlés

More Information

Publications:

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.

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.

Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol. 1989 Jan;92(1):122-5.

Berthod F, Hayek D, Damour O, Collombel C. Collagen synthesis by fibroblasts cultured within a collagen sponge. Biomaterials. 1993 Aug;14(10):749-54.

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.

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.

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.

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.

Study ID Numbers:	03F/DE01
Study First Received:	August 17, 2006
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00366041
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009