Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283426
Status:
TERMINATED
Last Update Posted:
2007-03-19
First Post:
2006-01-27
Brief Title:
Efficacy and Safety Study of Soluble Beta-1316-Glucan in Thermal Burns
Sponsor:
Biotec Pharmacon ASA
Organization:
Biotec Pharmacon ASA
Study Overview
Official Title:
An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1316-Glucan in Thermal Burns
Status:
TERMINATED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether soluble beta-1316-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested
Hypothesis Soluble beta-1316-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested
Hypothesis Soluble beta-1316-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested
Detailed Description:
In severe cases burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia tachypnea fever and leukocytosis and may progress to refractory hypotension Shock and multiple organ system dysfunction may subsequently occur Sepsis caused by infection or bacteremia is also a common occurrence and a major complication in burn patients
After cooling the burned area pain control is important Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection Such agents may have adverse local or systemic effects and may impede on the wound healing process itself The use of synthetic or biologic materials for wound covering is becoming increasingly popular but most of the clinical information about efficacy of such products are anecdotal
A primary objective in burn care is to have all wounds healed within 1 month With longer healing periods there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results
After cooling the burned area pain control is important Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection Such agents may have adverse local or systemic effects and may impede on the wound healing process itself The use of synthetic or biologic materials for wound covering is becoming increasingly popular but most of the clinical information about efficacy of such products are anecdotal
A primary objective in burn care is to have all wounds healed within 1 month With longer healing periods there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results
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