James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth

Ghent University Hospital (UZ)

Status

Completed

Conditions

Burns

Treatments

Procedure: Phototherapy with the Embar® light therapy or sham irradiation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00329654

2006/067

Details and patient eligibility

About

This will be a prospective, randomized, single blinded, controlled study in a single center setting to assess the effect of either phototherapy with the Embar® light therapy or sham irradiation.

Full description

This will be a prospective, randomized, single blinded, controlled study in a single center setting. Patients with burn wounds will be screened for enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated the first 48 to 72 hours with a hydrocolloid gel (Flaminal®) combined with Vaseline gauze. Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for Laser Doppler imaging, the burn wounds will be meticulously debrided during dressing changes. Patients whose burn wound meet the inclusion criteria will be randomized to receive either phototherapy with the Embar® light therapy or sham irradiation. Disinfection and topical treatment of the wounds will be the same in both groups as well as the treatment regimen after wound closure with special pressure garments and hydration.

Clinical wound assessments, wound tracings (if possible) and digital photographs will be conducted at least twice a week till wound healing. Swabs will be taken on admission, the day after laser Doppler imaging and from then on a weekly basis. Primary endpoint is complete epithelialization of the wound, secondary endpoint is maturation of the scar after one year. Follow-Ups will be performed one, three, six and twelve months after wound closure. The treatment regimen will consist of custom made pressure garments and hydration of the scar. Objective methods will be used during these follow-ups to evaluate elasticity and color of the scar, this by using the Dermalab and the Dermaspectrometer, as well as the Vancouver Scar Scale, a subjective method.

Enrollment

40 patients

Sex

All

Ages

2 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with expected healing time between 14 and 21 days, flux values between 200 and 600 (Pink-Yellow-Green-Light Blue color)
All burn wounds with above mentioned values and a maximal size of 8 by 10 cm.
Wounds treated with a hydrocolloid gel prior to LDI
All assessments are done during first days before scanning
Patients wish and possibility to follow the complete treatment schedule till wound healing and participation on complete follow-up schedule
Informed consent has been obtained

Exclusion criteria

All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with other healing times (Red and Dark blue color)
Impossibility to debride necrotic skin prior to LDI measurement
All burn wounds with values for inclusion but above the maximal wound size
Wounds treated with other topical ointments than hydrocolloids
Not following the complete treatment schedule or missing some evaluations during the follow-up period
Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this wound healing study
The plastic surgeon decides that surgery is necessary
Patients wish to terminate the study
No informed consent before start of the trial