Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
Not Applicable
Withdrawn
- Conditions
- Pressure Ulcer
- Interventions
- Device: AIRSOFT DUO for 1 dayDevice: SENTRY 1200 for 1 dayDevice: SENTRY 1200 for 1 monthDevice: AIRSOFT DUO for 1 month
- Registration Number
- NCT02735135
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
The secondary objectives of the study are to compare the two devices in terms of:
A. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 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
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Airsoft Duo First SENTRY 1200 for 1 month 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 Airsoft Duo First AIRSOFT DUO for 1 day 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 SENTRY 1200 First SENTRY 1200 for 1 day 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 SENTRY 1200 First AIRSOFT DUO for 1 month 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
- Primary Outcome Measures
Name Time Method Peak interface pressures at the sacral area (mmHg) Day 1
- Secondary Outcome Measures
Name Time Method Self-assessment for noise (Likert scale) Month 1 Self-assessment of sleep quality (visual analog scale) Month 1 Pressure ulcer development (yes/no) Month 1 Self-assessment of comfort by the patient (visual analog scale) Month 1 Body contact surface area (cm^2) Day 1 Peak pressure at the heel area (mmHg) Day 1
Trial Locations
- Locations (3)
Clinique de Soins de suite et réadaptation Saint Basile
🇫🇷Mougins, France
CH de Beziers
🇫🇷Béziers, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France