Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries

Burns Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366041
• Other study ID #: 03F/DE01
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2006
• Last updated: January 20, 2010
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Laboratoires Genévrier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Dermal substrate cellularised LG002 (10x10cm)
application depending on burn injury surface

Device:
• Dermal substrate uncellularised LG002 (10x10 cm)
depending on burn injury surface

Locations

Country	Name	City	State
France	Hôpital d' Instruction des Armées de Percy, Service des Brûlés	Clamart
France	Hôpital Cochin, Service des Brûlés	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoires Genévrier	Hôpital d'Instruction des Armées de Percy, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (9)

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

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. — View 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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)		6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002	No
Secondary	Short and medium term: Percentage of take of thin skin autografts 12 and 30 days after their application		12 and 30 days after their application	No
Secondary	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		1, 3, 6, 12 months	No
Secondary	Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance		each application	Yes
Secondary	Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)		1 and 6 months	No