James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth
Burns
About this trial
This is an interventional treatment trial for Burns focused on measuring Burn wounds, light therapy
Eligibility Criteria
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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Experimental
Embar® light therapy or sham irradiation
Phototherapy with the Embar® light therapy or sham irradiation.