Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366041
Status:
TERMINATED
Last Update Posted:
2010-01-21
First Post:
2006-08-17
Brief Title:
Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
Sponsor:
Laboratoires Genévrier
Organization:
Laboratoires Genévrier
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not appropriate to carry on the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
A primary siliconized dressing will cover the wound Secondary dressing dressing gauze impregnated with physiologic serum andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None