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Indicators for skin damage comparing two types of spineboard.


- candidate number17565
- NTR NumberNTR4537
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2014
- Secondary IDsABR nummer 49146 
- Public TitleIndicators for skin damage comparing two types of spineboard.
- Scientific TitleBiomarkers for soft tissue damage in a rigid and a soft-layered spineboard.
- ACRONYMBiomarkers spineboard
- hypothesisCytokine production differs when subjects ly on the rigid spineboard compared to the soft-layered spineboard.
- Healt Condition(s) or Problem(s) studiedPressure ulcers, Biomarkers, Comfort
- Inclusion criteria- Caucasian males
- Age 20-30 years
- Exclusion criteria- History of pressure ulcers
- Skin conditions
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-aug-2014
- Target number of participants10
- InterventionsSubjects ly on both spineboards for a period of three times twenty minutes. Photographs are made of the skin of the back/buttocks. Every twenty minutes sebutapes are (re)placed on in advance marked places of the skin. Tissue-interface pressures are registered continuously using a pressure mapping mat which is placed on top of the spineboard. Comfort is scored using a visual analog scale.
- Primary outcomeTissue-interface pressures as measured by a pressure mapping mat; redness of the skin; comfort of the spineboard.
- Secondary outcomeTissue-interface pressures as measured by a pressure mapping mat; redness of the skin; comfort of the spineboard.
- Timepoints1 hour, 2 hours
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Baukje Hemmes
- CONTACT for SCIENTIFIC QUERIESDrs. Baukje Hemmes
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications
- Brief summaryBackground of the study: Accident victims who are at risk for spinal column injury are transported to the hospital on a rigid spineboard, as indicated in protocols. Patient transport on a rigid spineboard has inherent risks: because of the rigid surface, there is a chance of developing pressure ulcers, especially when the patient lies on the rigid spineboard for a prolonged time. Furthermore, the lack of comfort due to lying on a rigid surface may cause unrest in the patient, leading to shifting to find a more comfortable position. When the patient has an unstable fracture of the spine, the shifting may lead to worsening of the injury. In the worst case, this may lead to paralysis due to (further) damage of the spinal cord by the moving fracture parts. It is therefore of utmost importance to be able to offer the patient an alternative, which accommodates the objections of discomfort and the risk of pressure ulcer development.

Objective of the study: In this study we want to investigate if there are differences in cytokine production when using a rigid and a soft-layered spineboard, in relation to tissue-interface pressures. Furthermore, redness of the skin and experienced comfort are documented.

Study design: Prospective, randomized intervention study

Study population: Caucasian males ages between 20 and 30 years of age, who have never had pressure ulcers en do not have skin problems at the time of the study.

Intervention: Subjects ly on both spineboards for a period of three times twenty minutes. Photographs are made of the skin of the back/buttocks. Every twenty minutes sebutapes are (re)placed on in advance marked places of the skin. Tissue-interface pressures are registered continuously using a pressure mapping mat which is placed on top of the spineboard. Comfort is scored using a visual analog scale.

Primary study parameters/outcome of the study: cytokine production

Secundary study parameters/outcome of the study (if applicable): Tissue-interface pressures as measured by a pressure mapping mat; redness of the skin; comfort of the spineboard.
- Main changes (audit trail)
- RECORD24-apr-2014 - 21-mei-2014


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