Novel Support Surface to Alleviate Pressure Ulcer

Not Applicable

Completed

• Conditions: Pressure Injury; Immobility Syndrome; Pressure Ulcer
• Interventions: Device: Novel support surface

• Registration Number: NCT04251897
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2020-09-02
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard care mattress	Novel support surface	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.
Novel support surface	Novel support surface	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.

Primary Outcome Measures

Name	Time	Method
PTAUC	For a maximum of 14 days (duration of trial)	pressure-time area under curve
Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade	For a maximum of 14 days (duration of trial)	If pressure sores are present, they will be graded based on the NPUAP grade from 1-4. Location will also be recorded.

Secondary Outcome Measures

Name	Time	Method
Patient's comfort	For a maximum of 14 days (duration of trial)	Patient comfort measured on a visual analogue scale (1- 10)
Discomfort or pain	For a maximum of 14 days (duration of trial)	Presence of discomfort or pain at high risk pressure points. This will be asked of patients, and will be scored as yes or no.
Suggestions	For a maximum of 14 days (duration of trial)	This will be a qualitative open-ended question for patient's verbatim report or suggestions

Trial Locations

Locations (1)

Tan Tock Seng Hospital Rehabilitation Centre; 🇸🇬 Singapore, Singapore