Observational Study for the Long-Term Effects of a Dermal Substitute on Patients With Facial Burns.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- POSAS Patient Scale Total Sum of Scores
Study Overview
Brief Summary
The aim of this observational study is to investigate the long-term (between 10-20 years) results for the surgical treatment of third degree burn injury in the face and/or the neck by means of Integra® Dermal Regeneration Template.
This study is an observational case-control study. The healthy skin of a comparable and/or contralateral skin-site of the face/neck serves as a comparator.
The population consists of human volunteers between 18 and 75 years old with third degree full thickness burn injuries in the face and/or neck, who underwent surgical treatment with IDRT between 1998 and 2008.
Detailed Description
Study Procedures
Description of the clinical-investigation-related procedures in order of occurrence.
All patients will respect a 30 minute acclimatisation period in the measurement room with standardised room temperature (20-22°C) and relative humidity (40-50%). Patients will be asked to remove their silicones and pressure garments the evening before the actual measurement. The scar site used for testing is marked with a circular adhesive marking with a diameter of 30 mm. A picture is taken to establish the location. The following optimal patient positions are recommended. The patient is lying on his back with the arms next to the body.
Order of occurrence:
- Intake questionnaire
- Digital photographs and video recording
- Patient and Observer Scar Assessment
- Colour measurement
- TEWL measurement
- Elasticity measurement
- Thickness measurement
- Quality of Life questionnaires
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subjects must be between 18 and 75 years old.
- •Third degree full thickness burn injuries in the face and/or neck
- •Having received surgical treatment with IDRT.
- •Underwent surgery between 1998 and 2008.
Exclusion Criteria
- •Subjects with no matching control site comparable with assessed body location.
Outcomes
Primary Outcomes
POSAS Patient Scale Total Sum of Scores
Time Frame: at enrolment
The POSAS Patient Scale contains six items (pain, itch, colour, thickness, pliability, texture) that are scored numerically on a ten-step scale from 1 (= healthy skin) to 10 (= worst imaginable scar). Together they make up the 'Total Sum of Scores'.
Secondary Outcomes
- Objective thickness measurements with High Frequency Ultrasound(at enrolment)
- Quality of Life Questionnaire BSHS-B(at enrollment)
- Objective elasticity measurements with Cutometer(at enrolment)
- Quality of Life Questionnaire EQ5D(at enrolment)
- POSAS Observer Scale Total Sum of Scores(at enrolment)
- Objective colour measurements with Mexameter(at enrolment)
- Objective TEWL measurements with Tewameter(at enrolment)
- Quality of Life Questionnaire SF-36(at enrollment)
Investigators
Yamina Dupont
Medical Doctor
Universitair Ziekenhuis Brussel