Novel Support Surface to Alleviate Pressure Ulcer

Tan Tock Seng Hospital

Status: Completed

Conditions: Immobility Syndrome; Pressure Ulcer; Pressure Injury

Treatments: Device: Novel support surface

Study type: Interventional

Funder types: Other

Identifiers

NCT04251897

DSRB 2019/00002

Details and patient eligibility

About

A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue

We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.

Enrollment: 10 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be immobile as assessed on the braden scale.
2. Patients must require 2 hourly turning
3. Age 21-85

Exclusion criteria

1. No existing pressure ulcers
2. No active infections, fever, or medical conditions that require constant medical attention.
3. They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours
4. No significant cognitive impairment
5. Pregnant women will be excluded from the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Standard care mattress

Active Comparator group

Description:

Patient will have 2 days to familiarize with the novel support surface. Patient will be on standard care mattress. They will be turned over every 2 hours for 3 days.

Treatment:

Device: Novel support surface

Novel support surface

Experimental group

Description:

After the standard care mattress, the same patient will be placed on novel support surface. They will be turned over every 2 hours for 3 days. Patient will then continue with the novel support surface and turned every 3 hours for 3 days. They will then continue with the novel support surface and turned every 4 hours for 3 days.

Treatment:

Device: Novel support surface