|- candidate number||28501|
|- NTR Number||NTR6979|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2018|
|- Secondary IDs||17-912/C METC-protocolnummer |
|- Public Title||Afdrukken in de huid, huidtemperatuur en comfort van twee nekkragen|
|- Scientific Title||Indentation marks, skin temperature and comfort of two cervical collars: a single-blinded randomized controlled trial|
|- hypothesis||There is a possibility that the Philadelphia neck collar gives better results than the stifneck collar on the proposed outcomes.|
|- Healt Condition(s) or Problem(s) studied||Comfort, Skin temperature, Indentation marks|
|- Inclusion criteria||Healthy volunteers|
18 till 65 years old
Speak and read the Dutch language
|- Exclusion criteria||Wound on and around the neck area, dermatologic diseases, blood circulation or pulmonary disorders, Diabetes Mellitus type I or II, previous spinal injuries or surgery, osteoporosis or spondylosis, use of analgesics in the past 24 hours, current neck pain, current pregnancy and chiropractic or physical therapy in the past six weeks.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2018|
|- planned closingdate||30-apr-2018|
|- Target number of participants||60|
|- Interventions||1. Laerdal Stifneck cervical collar|
2. Philadelphia Tracheatomy cervical collar
|- Primary outcome||Indentation marks divided in: none, mild and severe.|
|- Secondary outcome||Skin temperature measured in degree celsius and experienced comfort on a 5-point Likert scale|
|- Timepoints||T0: before immobilization in the cervical collar|
T1: after 20 minutes of immobilization in the cervical collar
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.P.L. Leenen|
|- CONTACT for SCIENTIFIC QUERIES|| J.P.L. Leenen|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Background|
Trauma patients who are immobilized with a cervical collar for preventive reasons, are at risk for developing collar related pressure ulcers (CRPU). There is a possibility that the Philadelphia cervical collar (C- collar) is a more favourable alternative for preventive immobilization using the Stifneck C-collar in trauma patients. However, the influence of risk factors for CRPU in the latest versions of these C-collars remains unclear due to lack of recent studies. Besides the patientsí condition, produced pressure, fit of the medical device and increased skin temperature seem relevant risk factors. It is possible that comfort and indentation marks (IM) are a sign of the exerted pressure and fit of the C-collar.
Primary Objective is to evaluate the effect of the Stifneck and Philadelphia cervical collar on incidence and severity of IM in immobilized healthy volunteers. Secondary Objectives are to evaluate the effect of the Stifneck and Philadelphia cervical collar on skin temperature and experienced comfort in immobilized healthy volunteers.
Single-blinded randomized controlled trial.
Healthy human volunteers from eighteen till 65 years old.
One group receives the Stifneck C-collar and the other group receives the Philadelphia C- collar. Both groups are immobilized for 20 minutes in the C-collar.
Main study parameters
The main study parameter is the incidence of IM at the end of the immobilization time divided in no, mild or severe IM. In addition, skin temperature is measured by an infrared thermometer and experienced comfort is assessed by a five-point Likert scale.
Difference between groups for the main parameter is tested by a Chi-square test. Secondary parameters are tested on differences by unpaired sample T-test and Chi-square test.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness
Participants have one site visit of about 30 minutes. There are no risks while participating in the study.
|- Main changes (audit trail)|
|- RECORD||26-jan-2018 - 2-feb-2018|