The main parameter of this study is the objective quantification of the biomechanical properties of skin and keloid/hypertrophic scars, as compared to the golden standard (Cutometer).The discriminating capacity will be tested by comparing healthy…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of this study is to determine whether OCT-based suction
elastometry is a proper tool to quantify elasticity of mature keloid and
hypertrophic scars and healthy skin in human subjects.
Secondary outcome
What is the concurrent validity of this device? Do the results correlate with
the item *pliability* of the POSAS.
Can we use this device for the analysis of pathological scars. Although this
device does not differ tremendously from the Cutometer, the feasibility needs
to be addressed in this pilot. Are the measurements practical and timely? Does
a single measurement provide sufficient data for the quantification of the
above mentioned parameters?
Can this device be used to measure scar specific differences in epidermal
thickness
Background summary
Stiffness and elasticity are important parameters in skin research and clinical
practice. These biomechanical factors are affected by both physiological and
pathological changes, of which scarring is the most common cause. Increased
stiffness in scars is a major part of the disease burden in the case of
hypertrophic scarring and keloids, and is therefore a target for multiple
therapies aimed at decreasing stiffness and increasing elasticity. Objective
quantification of the biomechanical characteristics of skin may be improved by
a multimodal approach: by combining suction-based deformation with Optical
Coherence Tomography imaging. This combination will be tested in this research
project by means of a novel medisch device developed at the Vrije Universiteit
Amsterdam.
Study objective
The main parameter of this study is the objective quantification of the
biomechanical properties of skin and keloid/hypertrophic scars, as compared to
the golden standard (Cutometer).The discriminating capacity will be tested by
comparing healthy skin and pathological scar tissue.
Study design
Pilot study
Study burden and risks
The trial entails 1 measurment moment with 3 measurements:
1) Measurement of scar biomechanics using the novel device (+-15minutes)
2) POSAS questionnaire (Patient and Observer Scar Assessment Scale) (+-15
minutes)
3) Measurement of scar biomechanics using golden standard (Cutometer) (+-
15minutes)
Risk assessment (See B24): Negligible
De Boelelaan 1117 De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117 De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Age: 18 years or older
* Competent
* Keloid or hypertrophic scar.
Exclusion criteria
* Language barrier
* Immature scar/open wounds
* Connective tissue disorders (e.g. Marfan, Ehlers Danlos, Cutis Laxa)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73352.029.21 |