Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position

June 5, 2018 updated by: MAH CHUN, Taipei Medical University Shuang Ho Hospital

In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.

The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.

Exclusion Criteria:

  1. under 20 years
  2. Patients have any skin lesion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery.
Device: Mepilex Border Sacrum
Patients use gel pad(in usual) in addition to use Mepilex Border Sacrum foam pad during surgery.
No Intervention: Control group
patients use gel pad(in usual) during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sacral pressure injury
Time Frame: After 1 hour surgery
After surgery check patient's sacral skin condition
After 1 hour surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Chun Mah, MS, Deputy Director of Nursing Department in Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 16, 2018

Primary Completion (Anticipated)

December 15, 2018

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107HCP-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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