Status:
COMPLETED
James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Tendris Holding BV
Conditions:
Burns
Eligibility:
All Genders
2-75 years
Phase:
NA
Brief Summary
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.
Detailed 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 ful...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00329654
Start Date
March 1 2006
End Date
December 1 2011
Last Update
July 31 2015
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000