search
Back to results

Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo (SPA2-INVACARE)

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Airsoft Duo mattress
Softform Premier mattress (in static mode)
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 Mattress, Preventing bed sores, Skin pressure

Eligibility Criteria

65 Years - undefined (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 with a possible verticalization and a predictable length of stay of at least 1 month.
  • The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers
  • The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale
  • The patient's weight is 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
  • Contra-indication for strict decubitus dorsal position
  • The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane.
  • The patient has bedsores, a recent scar in a pressure area.
  • The patient has a knee flexion deformity> 10 °
  • The patient is agitated or uncooperative
  • The patient's weight is greater than 120 Kg

Sites / Locations

  • EHPAD La Chimotaie
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • EHPAD Notre Dame des Pins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AirsoftDuo first

Softform Premium first

Arm Description

Patients randomized to this arm will be placed on the Airsoft Duo mattress, and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Softform Premium mattress (in static mode). The patient will then continue his/her stay with the Softform Premium mattress (in static mode) for 1 month. Intervention: Airsoft Duo mattress Intervention: Softform Premier mattress (in static mode)

Patients randomized to this arm will be placed on the Softform Premium mattress (in static mode), and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Airsoft Duo mattress. The patient will then continue his/her stay with the Airsoft Duo mattress for 1 month. Intervention: Softform Premier mattress (in static mode) Intervention: Airsoft Duo mattress

Outcomes

Primary Outcome Measures

Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet

Secondary Outcome Measures

Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet
Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Presence/absence of a pressure ulcer over the past month
Patient-rated comfort as measured by the visual analog scale
Visual analog scale ranging from 0 to 10

Full Information

First Posted
February 23, 2015
Last Updated
April 8, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Invacare Poirier S.A.S.
search

1. Study Identification

Unique Protocol Identification Number
NCT02380820
Brief Title
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
Acronym
SPA2-INVACARE
Official Title
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Invacare Poirier S.A.S.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of 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. contact surface. B. heel pressure. C. On the occurrence of pressure ulcers anywhere on the body at month 1. D. patient comfort after 1 month (visual analog scale ranging from 1 to 10).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Mattress, Preventing bed sores, Skin pressure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AirsoftDuo first
Arm Type
Experimental
Arm Description
Patients randomized to this arm will be placed on the Airsoft Duo mattress, and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Softform Premium mattress (in static mode). The patient will then continue his/her stay with the Softform Premium mattress (in static mode) for 1 month. Intervention: Airsoft Duo mattress Intervention: Softform Premier mattress (in static mode)
Arm Title
Softform Premium first
Arm Type
Experimental
Arm Description
Patients randomized to this arm will be placed on the Softform Premium mattress (in static mode), and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Airsoft Duo mattress. The patient will then continue his/her stay with the Airsoft Duo mattress for 1 month. Intervention: Softform Premier mattress (in static mode) Intervention: Airsoft Duo mattress
Intervention Type
Device
Intervention Name(s)
Airsoft Duo mattress
Intervention Description
A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).
Intervention Type
Device
Intervention Name(s)
Softform Premier mattress (in static mode)
Intervention Description
A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).
Primary Outcome Measure Information:
Title
Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet
Time Frame
Day 1
Title
Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Time Frame
Day 1
Title
Presence/absence of a pressure ulcer over the past month
Time Frame
1 month
Title
Patient-rated comfort as measured by the visual analog scale
Description
Visual analog scale ranging from 0 to 10
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Age (years)
Time Frame
Baseline (Day 0)
Title
Sex (F/M)
Time Frame
Baseline (Day 0)
Title
Weight (kg)
Time Frame
Baseline (Day 0)
Title
Height (cm)
Time Frame
Baseline (Day 0)
Title
Body mass index (kg/m^2)
Time Frame
Baseline (Day 0)
Title
Norton risk score
Time Frame
Baseline (Day 0)
Title
Albuminemia
Time Frame
Baseline (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 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 with a possible verticalization and a predictable length of stay of at least 1 month. The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale The patient's weight is 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 Contra-indication for strict decubitus dorsal position The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane. The patient has bedsores, a recent scar in a pressure area. The patient has a knee flexion deformity> 10 ° The patient is agitated or uncooperative The patient's weight is greater than 120 Kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Viollet, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
EHPAD La Chimotaie
City
Cugan Montaigu Cedex
ZIP/Postal Code
85610
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
EHPAD Notre Dame des Pins
City
Saint Privat des Vieux
ZIP/Postal Code
30340
Country
France

12. IPD Sharing Statement

Learn more about this trial

Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo

We'll reach out to this number within 24 hrs