No registrations found.
ID
Source
Health condition
spoke injuries, bicycle spoke injuries, wound,
Sponsors and support
Wilhelminalaan 12
1815 JD Alkmaar
s.wintermans@nwz.nl
072 - 548 4444
biodressings impregnated with polyhexamethylene are provided by Lohmann & Rausscher (no conflict of interests)
Intervention
Outcome measures
Primary outcome
pain
Secondary outcome
wound infection
time to healing
Background summary
A common mechanism of injury in the Netherlands is when a child gets stuck with his or her foot between te spokes of a riding bicycle. The best wound treatment of these spoke-injuries is unclear, and especially with bandage renewal and evaluation of the wound, patients can have significant pain.
In this study we try to investigate wether treatment with a biodressing impregnated with polyhexamethylene biguanide gives less pain than the usual treatment wich is a dressing with ointment.
The study design is a 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.
Study population will exist of children from 4-18 years with a spoke injury of the lower extremity.
Primary outcome is pain, as measured with a Faces Pain Scale-revised and a FLACC score. Secondary outcomes are duration of treatment and wound infection.
Study objective
wound treatment of foot and ankle injuries in children after a foot becomes caught in the spokes of a riding bicycle can be treated with less pain when using a biodressing impregnated with polyhexamethylene instead of the usual ointment gauze bandage
Study design
first contact at emergency department, [day0]
appointments with treating MD and 'gipsverbandmeester'(cast master) untill wound has healed
Intervention
wound treatment with biodressing impregnated with polyhexamethylene
S. Wintermans
Wilhelminalaan 12
Alkmaar 1815 JD
The Netherlands
072 - 548 4444
s.wintermans@nwz.nl
S. Wintermans
Wilhelminalaan 12
Alkmaar 1815 JD
The Netherlands
072 - 548 4444
s.wintermans@nwz.nl
Inclusion criteria
children 4-18 yrs
skin laceration/wound of foot and/or ankle after getting foot between spokes of a riding bicycle
Exclusion criteria
<4yrs
>18yrs
allergic to any of the products used in the investigation
indication for surgery of underlying bone, muscle or tendon
intact skin
follow-up in other hospital
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5475 |
NTR-old | NTR5892 |
CCMO | NL52326.094.15 |
OMON | NL-OMON44741 |