BurnsNCT00329654
James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth
A study of Burns, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Burns
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Phototherapy with the Embar® light therapy or sham irradiation
- Keywords
- Burn wounds, light therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with the Embar® light therapy or sham irradiationProcedure or surgery
Phototherapy with the Embar® light therapy or sham irradiation is followed.
| Study group | Role | What they receive |
|---|---|---|
| Embar® light therapy or sham irradiation | Experimental | Phototherapy with the Embar® light therapy or sham irradiation. Receives: Procedure: Phototherapy with the Embar® light therapy or sham irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
Measured: At time T0
Secondary outcomes (1)
Scar assessment
Scar assessment will be followed
Measured: 1 month, 3 months, 6 months and 1 year after wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Tendris Holding BV
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329654
- Sponsor's protocol ID
- 2006/067
- Status last verified
- Jul 2015
- First submitted
- 23 May 2006
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00329654
- Acronym / sponsor ID
- 2006/067
- Conditions
- Burns
- Keywords
- Burn wounds, light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Tendris Holding BV
- Study start
- Mar 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embar® light therapy or sham irradiation | Experimental | Procedure: Phototherapy with the Embar® light therapy or sham irradiationPhototherapy with the Embar® light therapy or sham irradiation. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phototherapy with the Embar® light therapy or sham irradiationPhototherapy with the Embar® light therapy or sham irradiation is followed. | Procedure or surgery | Embar® light therapy or sham irradiation |
Primary outcome
Wound closure
Time frame: At time T0
1 secondary outcome
Scar assessment
Time frame: 1 month, 3 months, 6 months and 1 year after wound closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Monstrey, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Burns, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure (time frame: At time T0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.