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Sponsors and Collaborators: |
University Hospital, Ghent Tendris Holding BV |
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Information provided by: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00329654 |
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.
Condition | Intervention |
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Burns |
Procedure: Phototherapy with the Embar® light therapy or sham irradiation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Single Blinded, Controlled Clinical Investigation of James Embar® Light Therapy in the Treatment of Burn Wounds With Little Healing Potential |
Estimated Enrollment: | 40 |
Study Start Date: | June 2006 |
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.
Ages Eligible for Study: | 2 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Henk Hoeksema, PT | 0032/(0)9/240.54.42 | henk.hoeksema@UGent.be |
Belgium | |
University Hospital Ghent | Recruiting |
Ghent, Belgium, 9000 | |
Contact: Henk Hoeksema, PT 0032/(0)9/240.54.42 henk.hoeksema@UGent.be | |
Principal Investigator: Henk Hoeksema, PT |
Principal Investigator: | Stan Monstrey, MD, PhD | University Hospital, Ghent |
Study ID Numbers: | 2006/067 |
Study First Received: | May 23, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00329654 |
Health Authority: | Belgium: Institutional Review Board |
Burn wounds, light therapy |
Burns Wounds and Injuries Disorders of Environmental Origin |