NCT01402765|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
31
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 11, 2012
Actual (reported)Study Completion
April 11, 2012
Actual (reported)The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 11, 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2011
Actual (reported)July 26, 2011
Actual (reported)March 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 11, 2012
Actual (reported)April 11, 2012
Actual (reported)Percentage of data capture time at < 30 mmHg (%)
Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at \< 30 mmHg
Day 1
Mean interface pressure (mmHg)
Day 1
Minimum interface pression (mmHg)
Day 1
Maximum interface pressure (mmHg)
Day 1
Percentage of data capture time where the pressures are changing (%)
Day 1
Matress tolerance: yes/no
Day 1
In Group 1 pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.
In Group 2 pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.
Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.
Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029, France
de Labachelerie C, Viollet E, Alonso S, Nouvel F, Bastide S, Blot M, Fagart W, Gelis A, Dupeyron A. Comparison of interface pressures in two dynamic pressure ulcer prevention supports (NIMBUS 3 and SUMMIT): A randomized controlled trial. J Tissue Viability. 2022 Feb;31(1):11-15. doi: 10.1016/j.jtv.2021.09.002. Epub 2021 Sep 11.
Emilie Viollet, MD
Centre Hospitalier Universitaire de Nīmes
31 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2011
First Posted
July 26, 2011
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 11, 2012
Actual (reported)Study Completion
April 11, 2012
Actual (reported)Last Updated
November 17, 2025
Record last verified: 2015-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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