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

NCT02380820 | Completed

• 2 other identifiers: LOCAL/2014/CEDMH-012014-A01214-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Pressure Ulcer

Keywords

Mattress; Preventing bed sores; Skin pressure

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (4)

• Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet

  Day 1

• Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet

  Day 1

• Presence/absence of a pressure ulcer over the past month

  1 month

• Patient-rated comfort as measured by the visual analog scale

  1 month

Other Outcomes (7)

• Age (years)

  Baseline (Day 0)

• Sex (F/M)

  Baseline (Day 0)

• Weight (kg)

  Baseline (Day 0)

Study Arms (2)

AirsoftDuo first

EXPERIMENTAL

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)

Device: Airsoft Duo mattress; Device: Softform Premier mattress (in static mode)

Softform Premium first

EXPERIMENTAL

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

Device: Airsoft Duo mattress; Device: Softform Premier mattress (in static mode)

Interventions

Airsoft Duo mattress DEVICE

A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).

AirsoftDuo first; Softform Premium first

Softform Premier mattress (in static mode) DEVICE

A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).

AirsoftDuo first; Softform Premium first

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Invacare Poirier S.A.S.: collaborator

Study Sites (3)

EHPAD La Chimotaie

Cugan Montaigu Cedex, 85610, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

EHPAD Notre Dame des Pins

Saint-Privat-des-Vieux, 30340, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emilie Viollet, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 5, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

FR (3)