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

Burns Clinical Trial

Official title:

An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00283426
• Other study ID #: SBG-1-10
• Status: Terminated
• Phase: Phase 1
• First received: January 27, 2006
• Last updated: March 16, 2007
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Soluble beta-1,3/1,6-glucan

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy parameters:
Primary	oedema
Primary	bleeding
Primary	pain on physical contact
Primary	exudation
Primary	capillary refill
Primary	reepithelialization
Primary	rubor
Primary	paleness
Primary	infectious discharge
Primary	smell
Primary	adherence of dressing
Primary	time since last dressing change
Primary	The efficacy parameters will be recorded during regular wound procedures
Secondary	Safety parameters:
Secondary	vital signs (heart rate, blood pressure, body temperature)
Secondary	adverse events
Secondary	laboratory parameters
Secondary	The safety parameters will be recorded daily during the first week of treatment and weekly thereafter