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

Pressure Ulcer Clinical Trial

— SPA2-INVACARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02380820
• Other study ID #: LOCAL/2014/CEDMH-01
• Secondary ID: 2014-A01214-43
• Status: Active, not recruiting
• Phase: N/A
• First received: February 23, 2015
• Last updated: March 21, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Airsoft Duo mattress
A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).
• Softform Premier mattress (in static mode)
A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).

Locations

Country	Name	City	State
France	EHPAD La Chimotaie	Cugan Montaigu Cedex
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	EHPAD Notre Dame des Pins	Saint Privat des Vieux

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Invacare Poirier S.A.S.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age (years)		Baseline (Day 0)	No
Other	Sex (F/M)		Baseline (Day 0)	No
Other	Weight (kg)		Baseline (Day 0)	No
Other	Height (cm)		Baseline (Day 0)	No
Other	Body mass index (kg/m^2)		Baseline (Day 0)	No
Other	Norton risk score		Baseline (Day 0)	No
Other	Albuminemia		Baseline (Day 0)	No
Primary	Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet		Day 1	No
Secondary	Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet		Day 1	No
Secondary	Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet		Day 1	No
Secondary	Presence/absence of a pressure ulcer over the past month		1 month	No
Secondary	Patient-rated comfort as measured by the visual analog scale	Visual analog scale ranging from 0 to 10	1 month	No