## Protocol Section
### Identification Module
**NCT ID:** NCT06438042

**Brief Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

**Official Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

#### Organization Study ID Info
**ID:** 2023-A01556-39
#### Organization
**Class:** INDUSTRY
**Full Name:** SYSTAM
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Clin-Experts

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** SYSTAM

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

### Conditions Module

**Conditions:**

- Pressure Ulcer

**Keywords:**

- Prevention

- Pressure ulcer

- Low air pressure motorised mattress

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies

**Label:** Patients in nursing homes or long-stay geriatrics department

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients in nursing homes or long-stay geriatrics department

**Description:** Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress

**Name:** Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)

**Measure:** Percentage of patients who developed at least one stage 2 pressure injury

**Time Frame:** 35 days after installation on the mattress (at day 35)

#### Secondary Outcomes

**Measure:** Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between

**Time Frame:** 35 days after installation on the mattress (at day 35)

**Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied)

**Measure:** Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)

**Time Frame:** 35 days after installation on the mattress (at day 35)

**Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied)

**Measure:** Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)

**Time Frame:** 35 days after installation on the mattress (at day 35)

**Description:** On a scale from 1 (constantly moist) to 4 rarely moist

**Measure:** Assessment of the degree of maceration

**Time Frame:** On a scale from 1 (constantly moist) to 4 rarely moist

**Description:** By collecting any adverse event or mattress malfunction during the follow up

**Measure:** Assessment of mattress safety

**Time Frame:** At day 35

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patient over 18 years old

Patient with high risk of developing pressure ulcers (clinical judgment and a score \<= 12 on the Braden scale (6 (maximum risk) to 23 (no risk)) Patient without pressure injury on the day of inclusion Patient up lying more than 20 hours a day on XTECH®25 mattress Patient with a weight \< 200 kg Patient (or a trusted third party) having been informed of the study and agreeing to participate

Exclusion Criteria:

* Patient at end of life (estimated life expectancy less than 6 months)
* Patient discharge from the establishment expected within two months
* Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines:

One or more of the following phenotypic criteria:

Significant unintentional weight loss:

A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months.

Low Body Mass Index (BMI):

BMI \< 18.5 kg/m² for individuals under 70 years old. BMI \< 21 kg/m² for individuals aged 70 years and older.

Reduced Muscle Mass:

Evident reduction in muscle mass.

AND

One of the following etiological criteria:

Inadequate nutritional intake:

Nutritional intake less than 50% of the energy requirements for more than one week.

Reduced food intake for more than two weeks.

Presence of Disease or Stress Metabolism:

Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements.

Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients in nursing homes or long-stay geriatrics department

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** contact@clin-experts.fr

**Name:** Renaud URBINELLI

**Phone:** 0756882093

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Multiple Locations

**Country:** France

**Facility:** Multiples locations

#### Overall Officials

**Official 1:**

**Affiliation:** Hôpital ROSCHILD

**Name:** Sylvie MEAUME

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Ulcer

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcer

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000014456

- Term: Ulcer

### Misc Info Module

- Version Holder: 2024-05-31
