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SPOKE trial


- candidate number24465
- NTR NumberNTR5892
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2016
- Secondary IDsNL52326.094.15 CCMO
- Public TitleSPOKE trial
- Scientific TitleEvaluation of different wound dressings in the treatment of children with spoke injuries (Evaluatie van verschillende verbandmiddelen in wondbehandeling bij kinderen met spaakverwondingen)
- ACRONYM
- hypothesiswound 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
- Healt Condition(s) or Problem(s) studiedSpoke injuries, Wound
- Inclusion criteriachildren 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2016
- planned closingdate1-jul-2017
- Target number of participants68
- Interventionswound treatment with biodressing impregnated with polyhexamethylene
- Primary outcomepain
- Secondary outcomewound infection
time to healing
- Timepointsfirst contact at emergency department, [day0]
appointments with treating MD and 'gipsverbandmeester'(cast master) untill wound has healed
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Wintermans
- CONTACT for SCIENTIFIC QUERIES S. Wintermans
- Sponsor/Initiator Noordwest Ziekenhuisgroep
- Funding
(Source(s) of Monetary or Material Support)
Noordwest Ziekenhuisgroep, Lohmann & Rausscher
- Publications
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD9-jun-2016 - 23-aug-2016


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