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Completed

NCT Number: NCT02380820

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD La Chimotaie, Cugan Montaigu Cedex, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airsoft Duo mattress

Device

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

Softform Premier mattress (in static mode)

Device

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

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

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

    Time frame: Day 1

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

    Time frame: Day 1

  3. Presence/absence of a pressure ulcer over the past month

    Time frame: 1 month

  4. Patient-rated comfort as measured by the visual analog scale

    Time frame: 1 month

    Visual analog scale ranging from 0 to 10

Other outcomes

  1. Age (years)

    Time frame: Baseline (Day 0)

  2. Sex (F/M)

    Time frame: Baseline (Day 0)

  3. Weight (kg)

    Time frame: Baseline (Day 0)

  4. Height (cm)

    Time frame: Baseline (Day 0)

  5. Body mass index (kg/m^2)

    Time frame: Baseline (Day 0)

  6. Norton risk score

    Time frame: Baseline (Day 0)

  7. Albuminemia

    Time frame: Baseline (Day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Invacare Poirier S.A.S.

Registry information

Acronym: SPA2-INVACARE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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