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

This study has suspended participant recruitment.
(Technical problems)
Sponsor:
Collaborator:
Tendris Holding BV
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00329654
First received: May 23, 2006
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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
Burns
Procedure: Phototherapy with the Embar® light therapy or sham irradiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Wound closure [ Time Frame: At time T0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scar assessment [ Time Frame: 1 month, 3 months, 6 months and 1 year after wound closure ] [ Designated as safety issue: No ]
    Scar assessment will be followed


Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Phototherapy with the Embar® light therapy or sham irradiation
    Phototherapy with the Embar® light therapy or sham irradiation is followed.
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.

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329654

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Tendris Holding BV
Investigators
Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Henk Hoeksema, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00329654     History of Changes
Other Study ID Numbers: 2006/067
Study First Received: May 23, 2006
Last Updated: June 29, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Burn wounds, light therapy

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014