To test the suitability of OCT for in vivo imaging of the vascularisation and surrounding tissue of burn wounds and scars.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the utility of OCT to perform objective assessment
of the vascularisation and surrounding tissue in burns and scars. Based on
previous studies we expect to see a loss of layered structure in (deep) burn
wounds and reduced to absent vascularisation. Moreover, a smaller birefringence
and collagen denaturation can be found in thermally injured skin. To quantify
the vascularisation in scars, we endeavour to identify the diameter of blood
vessels and obtain vessel density .
Secondary outcome
- Scar: colour, elasticity, subjective scar outcome assessed by the POSAS.
- Burn wound: depth assessment by the clinical impression of an experienced
burn clinician.
The secondary study parameters are not used for determination of the utility of
OCT but may be used to perform additional analyses.
E.g.: assessing agreement between colour measurement and vessel density
assessed by OCT.
Background summary
Vascularisation plays a key role in wound healing, scar formation, and
reconstructive surgery. In burns, the wound healing potential is based on the
depth of thermal injury and thereby on the residual intact vascularisation.
Imaging of the vascularisation of the (burn) wound will aid the understanding
of the healing potential and need for skin transplantation. Moreover, by
objectification of the vascularisation network, the possibilities for scar
evaluation will be optimized. For reconstructive procedures, improving the
understanding of tissue vascularisation will improve the outcome of the
surgery.
Non-invasive optical techniques that measure the vascularisation of the skin
can therefore be of paramount value in improving the outcome of burn- and
reconstructive surgery. One of the most promising optical techniques, Optical
Coherence Tomography, will be tested in this research project.
Study objective
To test the suitability of OCT for in vivo imaging of the vascularisation and
surrounding tissue of burn wounds and scars.
Study design
A pilot study will be performed in the Burn Centre of Beverwijk and the Plastic
& Reconstructive Surgery department of the Red Cross Hospital in Beverwijk.
Also, there may be patients included from the outpatient clinic. The study
results will not be used for diagnostic or therapeutic purposes. The study is
conducted to test the suitability of OCT in burn wounds and scars.
The accuracy of OCT will be tested by comparing the results of the measurement
device with those obtained from histology, though histologic examination will
be performed with residual tissue available from a planned operation.
Additionally, on every included scar a validated subjective scar assessment
scale (POSAS) will be used [van de Kar2005, Draaijers 2004a]. Furthermore,
colorimetry (DSMII) and elasticity measurements (Cutometer) will be performed
when possible [Draaijers2004c]. For burn wounds, subjective depth assessment
will also be done by experienced burn clinicians. The measurements will be
performed once on every patient, whereby no follow up is required. The total
duration of this study is one year.
Study burden and risks
There is no potential benefit for patients participating in this study, but the
experimental measurements may lead to an improved outcome in the future.
Burden:
- Single measurement with OCT during admission or outpatient clinic visit,
30-45 minutes
- In case of a scar: POSAS, elasticity and colour measurements, 15 minutes
- The measurements are carried out as much as possible during surgery.
Measurements are also performed in intubated patients so that they suffer no
discomfort. For this reason incompetent patients are included as well.
- Histological examination is performed with residual tissue available from a
planned operation.
Risks:
- An OCT measurement does not involve additional risks.
The burden and risks for a patient participating in this study is minimal.
Therefore we consider this study justifiable.
Vondellaan 13
Beverwijk 1942 LE
NL
Vondellaan 13
Beverwijk 1942 LE
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Competent or temporary incompetent (because of sedation and/or intubation)
Acute burn wound and a planned operation of the burn wound or:
Burn scar and an already planned excision (operation) of the scar
Exclusion criteria
Language barrier
Pre-existing vascular problems both acquired (venous or arterial diseases) or congenital (such
as vascular malformations)
(Possible) pregnancy
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 | NL46182.094.14 |