Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

NCT ID: NCT01402765

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-11

Brief Summary

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The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.

Detailed Description

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Conditions

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Chronic Immobile Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (Summit first)

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.

Group Type ACTIVE_COMPARATOR

Summit first

Intervention Type DEVICE

Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.

Group 2 (Nimbus 3 first)

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.

Group Type ACTIVE_COMPARATOR

Nimbus 3 first

Intervention Type DEVICE

Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.

Interventions

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Summit first

Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.

Intervention Type DEVICE

Nimbus 3 first

Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Bedridden patients that still have some measure of mobility, or that can change beds with assistance.
* Patients with symmetrical buttox support
* Body mass index between 16 and 35

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Strict decubitus dorsal position is contra-indicated
* State of agigation or non-cooperation
* Asymetrical deformation of the spine or hips in the frontal plane
* Bed sores present
* Evolving cardiac pathology
* Recent scar at a pressure interface
* Deep vein thrombosis
* Expected life span \< 24 weeks
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Viollet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34598852 (View on PubMed)

Other Identifiers

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LOCAL/2011/EV-06

Identifier Type: -

Identifier Source: org_study_id

2011-A00697-34

Identifier Type: OTHER

Identifier Source: secondary_id

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