NCT02412046

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

Terminated NA Last updated 23 December 2021

What this trial tests

NA trial testing Muscle biopsy in Pressure Ulcer in 21 participants. Terminated before completion.

Timeline

1 October 2015

Primary endpoint
2 October 2019

2 October 2019

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	21
Start date	1 October 2015
Primary completion	2 October 2019
Estimated completion	2 October 2019
Sites	1 location across France

Drugs / interventions tested

• Muscle biopsy

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →
• Bedsore — all drugs for Bedsore →
• Spinal Cord Injury — all drugs for Spinal Cord Injury →
• Paraplegia — all drugs for Paraplegia →

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 90, any sex, with Pressure Ulcer or Bedsore. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers.

The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting.

The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reactive Oxygen Species and Pressure Ulcer Formation after Traumatic Injury to Spinal Cord and Brain.
   Kumar S, Theis T, Tschang M, Nagaraj V, et al · · 2021 · cited 26× · PMID 34202655 · DOI 10.3390/antiox10071013