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

Primary Purpose

Pressure Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mepilex Border Sacrum

About this trial

This is an interventional prevention trial for Pressure Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

under 20 years
Patients have any skin lesion.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Patients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery.

patients use gel pad(in usual) during surgery.

Outcomes

Primary Outcome Measures

Sacral pressure injury

After surgery check patient's sacral skin condition

Secondary Outcome Measures

Full Information

NCT ID

NCT03557489

First Posted

June 5, 2018

Last Updated

June 5, 2018

Sponsor

Taipei Medical University Shuang Ho Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03557489

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 16, 2018 (Anticipated)

Primary Completion Date

December 15, 2018 (Anticipated)

Study Completion Date

February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Patients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

patients use gel pad(in usual) during surgery.

Intervention Type

Device

Intervention Name(s)

Mepilex Border Sacrum

Intervention Description

Patients use gel pad(in usual) in addition to use Mepilex Border Sacrum foam pad during surgery.

Primary Outcome Measure Information:

Title

Sacral pressure injury

Description

After surgery check patient's sacral skin condition

Time Frame

After 1 hour surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: under 20 years Patients have any skin lesion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chun Mah, MS

Phone

886-2-22490088

Ext

8601

machun786@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun Mah, MS

Organizational Affiliation

Deputy Director of Nursing Department in Shuang Ho Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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