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Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area (SPA2-ARSFT-DUO)

Primary Purpose

Pressure Ulcer

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AIRSOFT DUO for 1 day
SENTRY 1200 for 1 month
SENTRY 1200 for 1 day
AIRSOFT DUO for 1 month
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring bedridden

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Exclusion Criteria:

  • 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 °
  • 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

Sites / Locations

  • CH de Beziers
  • Clinique de Soins de suite et réadaptation Saint Basile
  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Airsoft Duo First

SENTRY 1200 First

Arm Description

Patients 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

Patients 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body contact surface area (cm^2)
Body contact surface area (cm^2)
Peak pressure at the heel area (mmHg)
Peak pressure at the heel area (mmHg)
Pressure ulcer development (yes/no)
Self-assessment of comfort by the patient (visual analog scale)
Self-assessment for noise (Likert scale)
Self-assessment of sleep quality (visual analog scale)

Full Information

First Posted
April 7, 2016
Last Updated
April 24, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Annie Bauer Confort
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1. Study Identification

Unique Protocol Identification Number
NCT02735135
Brief Title
Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
Acronym
SPA2-ARSFT-DUO
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
methodological difficulties
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Annie Bauer Confort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The secondary objectives of the study are to compare the two devices in terms of: A. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
bedridden

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Airsoft Duo First
Arm Type
Experimental
Arm Description
Patients 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
Arm Title
SENTRY 1200 First
Arm Type
Experimental
Arm Description
Patients 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
Intervention Type
Device
Intervention Name(s)
AIRSOFT DUO for 1 day
Intervention Description
The patient is placed on an AIRSOFT DUO mattress for 1 day.
Intervention Type
Device
Intervention Name(s)
SENTRY 1200 for 1 month
Intervention Description
The patient is placed on a SENTRY 1200 mattress for 1 month.
Intervention Type
Device
Intervention Name(s)
SENTRY 1200 for 1 day
Intervention Description
The patient is placed on a SENTRY 1200 mattress for 1 day.
Intervention Type
Device
Intervention Name(s)
AIRSOFT DUO for 1 month
Intervention Description
The patient is placed on an AIRSOFT DUO mattress for 1 month.
Primary Outcome Measure Information:
Title
Peak interface pressures at the sacral area (mmHg)
Time Frame
Day 0
Title
Peak interface pressures at the sacral area (mmHg)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Body contact surface area (cm^2)
Time Frame
Day 0
Title
Body contact surface area (cm^2)
Time Frame
Day 1
Title
Peak pressure at the heel area (mmHg)
Time Frame
Day 0
Title
Peak pressure at the heel area (mmHg)
Time Frame
Day 1
Title
Pressure ulcer development (yes/no)
Time Frame
Month 1
Title
Self-assessment of comfort by the patient (visual analog scale)
Time Frame
Month 1
Title
Self-assessment for noise (Likert scale)
Time Frame
Month 1
Title
Self-assessment of sleep quality (visual analog scale)
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: 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 ° 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Viollet, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CH de Beziers
City
Béziers
ZIP/Postal Code
34525
Country
France
Facility Name
Clinique de Soins de suite et réadaptation Saint Basile
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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