Clinical trial NCT00366041: Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Burns
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
Collaborators: name: Hôpital d'Instruction des Armées de Percy
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)
timeFrame: 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002
Secondary outcomes:
measure: Short and medium term: Percentage of take of thin skin autografts 12 and 30 days after their application
timeFrame: 12 and 30 days after their application
measure: 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
timeFrame: 1, 3, 6, 12 months
measure: Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance
timeFrame: each application
measure: Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d' Instruction des Armées de Percy, Service des Brûlés
city: Paris
country: France
facility: Hôpital Cochin, Service des Brûlés
Study officials:
affiliation: Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553
name: Christine DOSQUET, MD
role: STUDY_CHAIR
affiliation: Hôpital Cochin, Service des Brûlés
name: Daniel WASSERMANN, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
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citation: 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.