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

2014-08-27 03:42:56 | BioPortfolio


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.


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.

Study Design

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




Dermal substrate cellularised LG002 (10x10cm), Dermal substrate uncellularised LG002 (10x10 cm)


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




Laboratoires Genévrier

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:42:56-0400

Clinical Trials [534 Associated Clinical Trials listed on BioPortfolio]

Novel Compositions for Treating or Preventing Dermal Disorders

This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

Substrate Utilization and Hormonal Status in Women

Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal modific...

Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers

This study will determine if HA dermal filler late occurring (> 4 weeks and

Renuvion Dermal System for Dermal Resurfacing

This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.

Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C1...

PubMed Articles [2821 Associated PubMed Articles listed on BioPortfolio]

Dermal Autografts in Breast Reconstruction: A Review of Past and Current Trends.

Breast cancer affects 1 in 8 women. As the treatment of breast cancer evolves, breast reconstruction does as well. Implant-based reconstructions are increasing, leading to increased use of acellular d...

Human dermal fibroblast viability and adhesion on cellulose nanomaterial coatings: influence of surface characteristics.

Biodegradable and renewable materials, such as cellulose nanomaterials, have been studied as a replacement material for traditional plastics in the biomedical field. Furthermore, in chronic wound care...

Estrogens counteract the profibrotic effects of TGF-β and their inhibition exacerbates experimental dermal fibrosis.

Systemic sclerosis (SSc) primarily affects women. This sex bias raises the role of female hormones on fibrosis, which is largely unknown. Our aim was to evaluate the effects of estrogens in the develo...

Biomechanical response to distraction of hip capsular reconstruction with human acellular dermal patch graft.

The purpose was to quantify biomechanical properties of the hip capsule with human dermal allograft reconstruction in order to determine whether a dermal patch restored capsular resistance to distract...

Analysis of Abdominal Dermal-Fat Grafting to Repair Parotidectomy Defects: An 18-Year Cohort Study.

To assess the outcomes of abdominal dermal-fat grafting following superficial and total parotidectomy.

Medical and Biotech [MESH] Definitions

A set of opposing, nonequilibrium reactions catalyzed by different enzymes which act simultaneously, with at least one of the reactions driven by ATP hydrolysis. The results of the cycle are that ATP energy is depleted, heat is produced and no net substrate-to-product conversion is achieved. Examples of substrate cycling are cycling of gluconeogenesis and glycolysis pathways and cycling of the triglycerides and fatty acid pathways. Rates of substrate cycling may be increased many-fold in association with hypermetabolic states resulting from severe burns, cold exposure, hyperthyroidism, or acute exercise.

Synthetic material used for the treatment of burns and other conditions involving large-scale loss of skin. It often consists of an outer (epidermal) layer of silicone and an inner (dermal) layer of collagen and chondroitin 6-sulfate. The dermal layer elicits new growth and vascular invasion and the outer layer is later removed and replaced by a graft.

Arginine derivative which is a substrate for many proteolytic enzymes. As a substrate for the esterase from the first component of complement, it inhibits the action of C(l) on C(4).

A characteristic feature of enzyme activity in relation to the kind of substrate on which the enzyme or catalytic molecule reacts.

A chromogenic substrate that permits direct measurement of peptide hydrolase activity, e.g., papain and trypsin, by colorimetry. The substrate liberates p-nitroaniline as a chromogenic product.

More From BioPortfolio on "Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries"

Quick Search

Relevant Topics

Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Searches Linking to this Trial