Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2022
• Main ID: NCT02412046
• Date of registration: 03/04/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Montpellier
• Public title: Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
• Scientific title: Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
• Date of first enrolment: October 1, 2015
• Target sample size: 21
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02412046
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Educated consent signed,

- Older than 18,

- Paraplegia for at least 6 months,

- Patient's Body Mass Index > 18,5kg/m²,

- Surgery planned for pressure ulcer resection,

- Pressure Ulcer classification (EPUAP) at least III or IV

Exclusion Criteria:

- Cardiac pathology,

- Duchenne muscular dystrophy,

- Dementia,

- Presence of a tumourous wound,

- Stade IV arteritis non-revascularisable,

- Diabetes mellitus,

- Cachexia,

- Impossibility to stop the anti-coagulant treatment 24 hours before the patient
admission,

- Xylocaine allergy,

- Patient took aspirin or anti-inflammatory 3 days before the biopsy,

- Patient taking part in another study,

- Patient with no health insurance,

- Pregnant women or breast-feeding, patient unable to give his or her educated consent,
ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9)



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pressure Ulcer

Spinal Cord Injury

Bedsore

Paraplegia

Intervention(s)

Procedure: Muscle biopsy

Primary Outcome(s)

The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours. [Time Frame: The first day of the patient admission (during the first 3 hours).]

Secondary Outcome(s)

The microvascularization changes underneath the compressed skin and the inflammatory response of the muscle cells. [Time Frame: The first day of the patient admission (during the first 3 hours).]

Secondary ID(s)

95022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hill-Rom