search
Back to results

Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

Primary Purpose

Burns

Status
Terminated
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Soluble beta-1,3/1,6-glucan
Sponsored by
Biotec Pharmacon ASA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age >= 18 years written informed consent Group A - patients with thermal burns partial thickness burns (2nd degree) requiring non-surgical primary treatment primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included or Group B - patients with thermal burns non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included or Group C - patients with thermal burns donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included Exclusion Criteria: inhalation injury to airways and lungs chemical or high voltage electrical burn pregnancy, lactation clinical signs or symptoms of acute infection any prescription or non-prescription topical medication administered within one week prior to study start hematological and clinical/chemical parameteres judged as unacceptable by the investigator donor sites with re-harvesting previous treatment with soluble beta-1,3/1,6-glucan participation in other clinical studies in the last 4 weeks

Sites / Locations

  • Haukeland University Hospital

Outcomes

Primary Outcome Measures

Efficacy parameters:
oedema
bleeding
pain on physical contact
exudation
capillary refill
reepithelialization
rubor
paleness
infectious discharge
smell
adherence of dressing
time since last dressing change
The efficacy parameters will be recorded during regular wound procedures

Secondary Outcome Measures

Safety parameters:
vital signs (heart rate, blood pressure, body temperature)
adverse events
laboratory parameters
The safety parameters will be recorded daily during the first week of treatment and weekly thereafter

Full Information

First Posted
January 27, 2006
Last Updated
March 16, 2007
Sponsor
Biotec Pharmacon ASA
search

1. Study Identification

Unique Protocol Identification Number
NCT00283426
Brief Title
Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Official Title
An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Terminated
Why Stopped
Slow patient recruitment
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Biotec Pharmacon ASA

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested. Hypothesis: Soluble beta-1,3/1,6-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Soluble beta-1,3/1,6-glucan
Primary Outcome Measure Information:
Title
Efficacy parameters:
Title
oedema
Title
bleeding
Title
pain on physical contact
Title
exudation
Title
capillary refill
Title
reepithelialization
Title
rubor
Title
paleness
Title
infectious discharge
Title
smell
Title
adherence of dressing
Title
time since last dressing change
Title
The efficacy parameters will be recorded during regular wound procedures
Secondary Outcome Measure Information:
Title
Safety parameters:
Title
vital signs (heart rate, blood pressure, body temperature)
Title
adverse events
Title
laboratory parameters
Title
The safety parameters will be recorded daily during the first week of treatment and weekly thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >= 18 years written informed consent Group A - patients with thermal burns partial thickness burns (2nd degree) requiring non-surgical primary treatment primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included or Group B - patients with thermal burns non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included or Group C - patients with thermal burns donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included Exclusion Criteria: inhalation injury to airways and lungs chemical or high voltage electrical burn pregnancy, lactation clinical signs or symptoms of acute infection any prescription or non-prescription topical medication administered within one week prior to study start hematological and clinical/chemical parameteres judged as unacceptable by the investigator donor sites with re-harvesting previous treatment with soluble beta-1,3/1,6-glucan participation in other clinical studies in the last 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjostolv Lund, Dr.med.
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

We'll reach out to this number within 24 hrs