Evaluation of different wound dressings in the treatment of children with spoke injuries

Evaluation of different wound dressings in the treatment of children with spoke injuries - SPOKE-trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44741

Enrollment

108

Registered

2016-04-26

Start date

2016-07-03

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

injury after a foot between bicycle spokes spokewound

Interventions

wound management with a biodressing impregnated with polyhexamethylene biguanide (SuprasorbX-PHMB)

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Pain, as measured with Faces pain scale revised and a FLACC score	—

Secondary

Measure	Time frame
length of treatment in days development of wound infection as scored with South-Hampton wound assessment scale	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)