To study wether a biodressing impregnated with polyhexamethylene biguanide in the treatment of spoke injuries in children could give a reduction in pain during the treatment compared to the standard treatment with wound dressing impregnated with
ID
Source
Brief title
Condition
- Injuries NEC
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain, as measured with Faces pain scale revised and a FLACC score
Secondary outcome
length of treatment in days
development of wound infection as scored with South-Hampton wound assessment
scale
Background summary
In the Netherlands most people ride a bicycle, but there are some risks
entailed. Especially when children are riding along at the front or the back of
the bicycle. It is possible for them to get there foot entamgled between the
spokes of a riding bicycle, a so called spoke injury. Every year aproximately
2800 patients are presented on the emergency departments in the Netherlands. On
the Emergency department in our hospital ecery year around 100 children are
seen with spoke injuries. The treatment usually is a dressing with ointment or
a silicone based wound dressing covered with a casted splint. At check up these
wound dressings have to be removed to evaluate the wound. In the, often very
young, patients this can be experienced as a painful procedure and check-ups
can become a traumatising event.
Treatment with a biodressing impregnated with polyhexamethylene biguanide could
offer some solution. This sort of dressing has been used in chronic and
infected wounds. Treatment of spoke injuries in a small study in Amsterdam
described good healing without infections. An important benefit coudl be a
reduction in pain during treatment because the dressing doesn't have to be
changed an you can see through it to check for any problems. The above
mentioned study mentions a reduction in pain, there has however never been a
study with a control group. Hypothesis is that this biodressing wth
polyhexamethylene biguanide could reduce pain, and the use of this dressing in
the emergency department at the start of the treatment of the spoke injury coud
be of benefit for the patients during the length of the treatment.
Study objective
To study wether a biodressing impregnated with polyhexamethylene biguanide in
the treatment of spoke injuries in children could give a reduction in pain
during the treatment compared to the standard treatment with wound dressing
impregnated with
Study design
Randomised controlled trial, in wich the two treatments are compared: standard
treatment with wound-dressing with ointment to prevent adhesion to the wound
compared to biodressing impregnated with polyhexamethylene biguanide.
Intervention
wound management with a biodressing impregnated with polyhexamethylene
biguanide (SuprasorbX-PHMB)
Study burden and risks
Low burden, measurement of pain with pointing to a picture (Faces pain scale)
for the patient and a short questionnaire (FLACC-score) for the
parents/providers
The risk is low, there have been no allergic reactions described, previous
study had no wound infections with the intervention treatment.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
Children of 4 years of age and older.
Presentation within 72 hours after trauma
Wound on foot and/or ankle after inury where foot has been stuck in between spokes of riding bicycle.
Exclusion criteria
Children younger than 4 years,
Adults
unable to score pain on painscale
Allergic to a component of one of the bandages
Indication for surgery of underlying muscle, tendon or bone
No skin defect
Follow-up in another hospital
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
In other registers
Register | ID |
---|---|
CCMO | NL52326.094.15 |
OMON | NL-OMON24131 |