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

NCT ID: NCT00283426

Last Updated: 2007-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-03-31

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.

Conditions

Burns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Soluble beta-1,3/1,6-glucan

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotec Pharmacon ASA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Tjostolv Lund, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

SBG-1-10

Identifier Type: -

Identifier Source: org_study_id