SPA2-ARSFT-DUO: Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02735135
• Collaborator: Annie Bauer Confort (Other)
• Enrollment: 0
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Device: AIRSOFT DUO for 1 day; Device: SENTRY 1200 for 1 month; Device: SENTRY 1200 for 1 day; Device: AIRSOFT DUO for 1 month	N/A

Detailed Description

The secondary objectives of the study are to compare the two devices in terms of:

1. 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study
• Anticipated Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Airsoft Duo First 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 day; The patient is placed on an AIRSOFT DUO mattress for 1 day.; Device: SENTRY 1200 for 1 month; The patient is placed on a SENTRY 1200 mattress for 1 month.
Experimental: SENTRY 1200 First 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 day; The patient is placed on a SENTRY 1200 mattress for 1 day.; Device: AIRSOFT DUO for 1 month; The patient is placed on an AIRSOFT DUO mattress for 1 month.

Outcome Measures

Primary Outcome Measures

1. Peak interface pressures at the sacral area (mmHg) [Day 0]

2. Peak interface pressures at the sacral area (mmHg) [Day 1]

Secondary Outcome Measures

1. Body contact surface area (cm^2) [Day 0]

2. Body contact surface area (cm^2) [Day 1]

3. Peak pressure at the heel area (mmHg) [Day 0]

4. Peak pressure at the heel area (mmHg) [Day 1]

5. Pressure ulcer development (yes/no) [Month 1]

6. Self-assessment of comfort by the patient (visual analog scale) [Month 1]

7. Self-assessment for noise (Likert scale) [Month 1]

8. Self-assessment of sleep quality (visual analog scale) [Month 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH de Beziers	Béziers		France	34525
2	Clinique de Soins de suite et réadaptation Saint Basile	Mougins		France	06250
3	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes
• Annie Bauer Confort

Investigators

• Study Director: Emilie Viollet, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT02735135
• Other Study ID Numbers: LOCAL/2016/CEDMH-01; 2016-A00188-43
• First Posted: Apr 12, 2016
• Last Update Posted: Apr 25, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Nīmes: bedridden
• Additional relevant MeSH terms: Pressure Ulcer

Study Results

No Results Posted as of Apr 25, 2019