Viewing Study NCT00329654



Ignite Creation Date: 2024-05-05 @ 4:51 PM
Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00329654
Status: COMPLETED
Last Update Posted: 2015-07-31
First Post: 2006-05-23

Brief Title: James EMBAR Light Therapy in the Treatment of Burn Wounds of Intermediate Depth
Sponsor: University Hospital Ghent
Organization: University Hospital Ghent

Study Overview

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
Status: COMPLETED
Status Verified Date: 2015-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None