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

NCT00366041 | Terminated Phase 2 DMC

• 1 other identifier: 03F/DE01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance

  each application

• Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)

  1 and 6 months

Study Arms (2)

Cellularised LG002

EXPERIMENTAL

Cellularised LG002

Drug: Dermal substrate cellularised LG002 (10x10cm)

UnCellularised LG002

EXPERIMENTAL

UnCellularised LG002

Device: Dermal substrate uncellularised LG002 (10x10 cm)

Interventions

Dermal substrate cellularised LG002 (10x10cm) DRUG

application depending on burn injury surface

Cellularised LG002

Dermal substrate uncellularised LG002 (10x10 cm) DEVICE

depending on burn injury surface

UnCellularised LG002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Genévrier: lead
• Hôpital d'Instruction des Armées de Percy: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Hôpital d' Instruction des Armées de Percy, Service des Brûlés

Clamart, 92141, France

Location

Hôpital Cochin, Service des Brûlés

Paris, 75679, France

Location

Related Publications (9)

• 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.

  PMID: 10147169 BACKGROUND

• 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.

  PMID: 10147171 BACKGROUND

• 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.

  PMID: 2909624 BACKGROUND

• 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.

  PMID: 8218724 BACKGROUND

• 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.

  PMID: 12799215 BACKGROUND

• 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.

  PMID: 8105612 BACKGROUND

• 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.

  PMID: 6356519 BACKGROUND

• 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.

  PMID: 11513518 BACKGROUND

• 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.

  PMID: 9623833 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Christine DOSQUET, MD

  Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553

  STUDY CHAIR

• Daniel WASSERMANN, PhD, MD

  Hôpital Cochin, Service des Brûlés

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 18, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

FR (2)