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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Phototherapy with the Embar® light therapy or sham irradiation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burn wounds, light therapy

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embar® light therapy or sham irradiation

Arm Description

Phototherapy with the Embar® light therapy or sham irradiation.

Outcomes

Primary Outcome Measures

Wound closure

Secondary Outcome Measures

Scar assessment
Scar assessment will be followed

Full Information

First Posted
May 23, 2006
Last Updated
July 30, 2015
Sponsor
University Hospital, Ghent
Collaborators
Tendris Holding BV
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1. Study Identification

Unique Protocol Identification Number
NCT00329654
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Tendris Holding BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn wounds, light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embar® light therapy or sham irradiation
Arm Type
Experimental
Arm Description
Phototherapy with the Embar® light therapy or sham irradiation.
Intervention Type
Procedure
Intervention Name(s)
Phototherapy with the Embar® light therapy or sham irradiation
Intervention Description
Phototherapy with the Embar® light therapy or sham irradiation is followed.
Primary Outcome Measure Information:
Title
Wound closure
Time Frame
At time T0
Secondary Outcome Measure Information:
Title
Scar assessment
Description
Scar assessment will be followed
Time Frame
1 month, 3 months, 6 months and 1 year after wound closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Monstrey, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

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

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