NCT02735135

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

April 7, 2016

Last Update Submit

April 24, 2019

Conditions

Pressure Ulcer

Keywords

bedridden

Outcome Measures

Primary Outcomes (2)

  • Peak interface pressures at the sacral area (mmHg)

    Day 0

  • Peak interface pressures at the sacral area (mmHg)

    Day 1

Secondary Outcomes (8)

  • Body contact surface area (cm^2)

    Day 0

  • Body contact surface area (cm^2)

    Day 1

  • Peak pressure at the heel area (mmHg)

    Day 0

  • Peak pressure at the heel area (mmHg)

    Day 1

  • Pressure ulcer development (yes/no)

    Month 1

  • +3 more secondary outcomes

Study Arms (2)

Airsoft Duo First

EXPERIMENTAL

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

Device: AIRSOFT DUO for 1 dayDevice: SENTRY 1200 for 1 month

SENTRY 1200 First

EXPERIMENTAL

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

Device: SENTRY 1200 for 1 dayDevice: AIRSOFT DUO for 1 month

Interventions

AIRSOFT DUO for 1 dayDEVICE

The patient is placed on an AIRSOFT DUO mattress for 1 day.

Airsoft Duo First
SENTRY 1200 for 1 monthDEVICE

The patient is placed on a SENTRY 1200 mattress for 1 month.

Airsoft Duo First
SENTRY 1200 for 1 dayDEVICE

The patient is placed on a SENTRY 1200 mattress for 1 day.

SENTRY 1200 First
AIRSOFT DUO for 1 monthDEVICE

The patient is placed on an AIRSOFT DUO mattress for 1 month.

SENTRY 1200 First

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), 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 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CH de Beziers

Béziers, 34525, France

Location

Clinique de Soins de suite et réadaptation Saint Basile

Mougins, 06250, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Emilie Viollet, MD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR
0

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

April 7, 2016

First Posted

April 12, 2016

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations

FR(3)