With this study we want to validate the negative pressure instrument which can make suction blisters, so in the future it can be used for other purposes. It can be helpfull to study the effects of medication or other treatments on blister formation…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders congenital
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Induction time of suction blisters and level of blister formation in the skin
Secondary outcome
-
Background summary
The department dermatology of the UMC Groningen is a specialised centre for
patients with a blister disease. Research studies concerning congenital and
auto-immune blister diseases made it a top reference centre in the Netherlands.
This study concerns suction blisters, made on healthy subjects and on subjects
with an blister disease. Because this is the first study in Groningen where we
use suctioncblisters, it is the start of a whole new research topic in the
excisting programme concerning blister diseases.
Study objective
With this study we want to validate the negative pressure instrument which can
make suction blisters, so in the future it can be used for other purposes. It
can be helpfull to study the effects of medication or other treatments on
blister formation of the skin. Furthermore this study provides more information
about the induction time of suction blisters and the level of blister formation
in the skin in healthy subjects and subjects with an auto-immune blister
disease.
Study design
Intervention study that, for a part, will take place on the polyclinic of the
dermatology department in the UMC Groningen. Healthy subjects will be recruited
in the hostipal, people who work here can voluntary participate in the study.
They will be researchgroup 1. Patients known in the UMCG with a blister disease
who fit the inclusion criteria will be send a letter en asked if they want to
participate in the study. These subjects will form researchgroup 2 and 3,
depending on the type of blister disease they suffer from.
On all the subjects a suction blister will be made and induction times are
recorded. Then a biopsy of the blister will be done in group 3, and the skin
will be sutured to prevent infection of the wound. A protocol for the treatment
of the wound will be made and applied. The biopsies are investigated in the
immunodermatology laboratory of the UMCG, where the level of blister formation
is recorded. The induction times and the level of blister formation will be
compared between the three research groups.
Intervention
1. making a suction blister (diameter: 1cm)
2. local anaesthetic of the wound
3. biopsy (4mm) of the blister
4. suture of the skin (ethylon 5.0)
Study burden and risks
Subjects are asked to visit the polyclinic once, this visit will take about 60
minutes. Where possible, this visit will be combined with an excisting
appointment with their own docter. If this is not possible, subjects can get a
compensation for the costs they made to travel to the hospital.
After a biopsy there is always the risk of infection. To make this risk as low
as possible, the wound will be sutured and a woudprotocol will be applied.
tjalling harkeswei 95A
9241 HM Wijnjewoude
Nederland
tjalling harkeswei 95A
9241 HM Wijnjewoude
Nederland
Listed location countries
Age
Inclusion criteria
group 1: healthy, age > 18 years, no skindisease or other disease that can influence blisterformation
group 2: patients with epidermolysis bullosa, age >18 years
group 3: patients with auto-immune blisterdisease, age >18 years
Exclusion criteria
group 1: people with a blisterdisease or an other disease that can influence blister formation, age < 18 years
group 2: age < 18 years
group 3: age < 18 years
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 | NL25089.042.08 |