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Tracking Information | |||||
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First Received Date † | May 23, 2006 | ||||
Last Updated Date | April 9, 2009 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
Wound closure | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00329654 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Scar assessment 1 month, 3 months, 6 months and 1 year after wound closure | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth | ||||
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 | ||||
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. |
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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 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study | ||||
Condition † | Burns | ||||
Intervention † | Procedure: Phototherapy with the Embar® light therapy or sham irradiation | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 40 | ||||
Estimated Completion Date | December 2009 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Belgium | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00329654 | ||||
Responsible Party | Henk Hoeksema, University Hospital Ghent | ||||
Secondary IDs †† | |||||
Study Sponsor † | University Hospital, Ghent | ||||
Collaborators †† | Tendris Holding BV | ||||
Investigators † |
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Information Provided By | University Hospital, Ghent | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |