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Pressure UlcerSPA2-ARSFT-DUONCT02735135

Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area

A study testing AIRSOFT DUO for 1 day, SENTRY 1200 for 1 month and SENTRY 1200 for 1 day in people with Pressure Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pressure Ulcer
What is being tested?
AIRSOFT DUO for 1 day, SENTRY 1200 for 1 month and SENTRY 1200 for 1 day
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesFrance
Study dates
Jan 2019to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient spends more than 12 hours in bed and verticalisation is possible
  • The patient has a stable medical condition (no complication in the last 10 days) and no visible pressure ulcers
  • The patient is at risk for pressure ulcers as assessed by a score ≤ 15 on the Braden Scale
  • The patient weighs less than 120 kg

Who cannot join

  • 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
  • The subject has a contra-indication for a strictly supine position
  • The patient has a knee flexion deformity > 10 °
Show all 9Show fewer
  • The patient is in a state of agitation or refuses to cooperate
  • The patient's weight is greater than 120 Kg
  • The length of stay is less than one month

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CH de Beziers

    Béziers, 34525

  • Clinique de Soins de suite et réadaptation Saint Basile

    Mougins, 06250

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study

The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area.

Read the detailed description

The secondary objectives of the study are to compare the two devices in terms of:

  1. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).
Conditions
Pressure Ulcer
Being tested
AIRSOFT DUO for 1 day, SENTRY 1200 for 1 month, SENTRY 1200 for 1 day, AIRSOFT DUO for 1 month
Keywords
bedridden
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIRSOFT DUO for 1 dayDevice

    The patient is placed on an AIRSOFT DUO mattress for 1 day.

  • SENTRY 1200 for 1 monthDevice

    The patient is placed on a SENTRY 1200 mattress for 1 month.

  • SENTRY 1200 for 1 dayDevice

    The patient is placed on a SENTRY 1200 mattress for 1 day.

  • AIRSOFT DUO for 1 monthDevice

    The patient is placed on an AIRSOFT DUO mattress for 1 month.

Study groups in NCT02735135
Study groupRoleWhat they receive
Airsoft Duo FirstExperimentalPatients randomized to this arm will be placed on an AIRSOFT DUO mattress for day 0. They will then be switched to a SENTRY 1200 mattress until the end of month 1. Intervention: AIRSOFT DUO for 1 day Intervention: SENTRY 1200 for 1 month
Receives: Device: AIRSOFT DUO for 1 day; Device: SENTRY 1200 for 1 month
SENTRY 1200 FirstExperimentalPatients randomized to this arm will be placed on a SENTRY 1200 mattress for day 0. They will then be switched to an AIRSOFT DUO mattress until the end of month 1. Intervention: SENTRY 1200 for 1 day Intervention: AIRSOFT DUO for 1 month
Receives: Device: SENTRY 1200 for 1 day; Device: AIRSOFT DUO for 1 month

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak interface pressures at the sacral area (mmHg)

    Measured: Day 0

  2. Peak interface pressures at the sacral area (mmHg)

    Measured: Day 1

Secondary outcomes (8)

  1. Body contact surface area (cm^2)

    Measured: Day 0

  2. Body contact surface area (cm^2)

    Measured: Day 1

  3. Peak pressure at the heel area (mmHg)

    Measured: Day 0

  4. Peak pressure at the heel area (mmHg)

    Measured: Day 1

  5. Pressure ulcer development (yes/no)

    Measured: Month 1

  6. Self-assessment of comfort by the patient (visual analog scale)

    Measured: Month 1

  7. Self-assessment for noise (Likert scale)

    Measured: Month 1

  8. Self-assessment of sleep quality (visual analog scale)

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startJan 2019 (estimated)
  3. Primary completionJul 2019 (estimated)
  4. Study completionAug 2019 (estimated)

Why it stopped: methodological difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02735135
Sponsor's protocol ID
LOCAL/2016/CEDMH-01
Other IDs
2016-A00188-43
Acronym
SPA2-ARSFT-DUO
Status last verified
Apr 2019
First submitted
7 Apr 2016
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AIRSOFT DUO for 1 day, SENTRY 1200 for 1 month and SENTRY 1200 for 1 day in people with Pressure Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak interface pressures at the sacral area (mmHg) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02735135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.

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