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

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ClinicalTrials.gov Identifier: NCT03557489
Recruitment Status : Unknown
Verified June 2018 by MAH CHUN, Taipei Medical University Shuang Ho Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
MAH CHUN, Taipei Medical University Shuang Ho Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Mepilex Border Sacrum Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position
Estimated Study Start Date : June 16, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : February 28, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Sacral pressure injury [ Time Frame: After 1 hour surgery ]
    After surgery check patient's sacral skin condition


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. under 20 years
  2. Patients have any skin lesion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557489


Contacts
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Contact: Chun Mah, MS 886-2-22490088 ext 8601 machun786@gmail.com

Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Chun Mah, MS Deputy Director of Nursing Department in Shuang Ho Hospital
More Information
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Responsible Party: MAH CHUN, Deputy Director of Nursing Department, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03557489    
Other Study ID Numbers: 107HCP-08
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pressure Ulcer
Crush Injuries
Skin Ulcer
Skin Diseases
Wounds and Injuries