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NCT03557489 Clinical Trial

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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03557489
Other study ID # 107HCP-08
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 16, 2018
Est. completion date February 28, 2019

Study information
Verified date June 2018
Source Taipei Medical University Shuang Ho Hospital
Contact Chun Mah, MS
Phone 886-2-22490088
Email machun786@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 210
Est. completion date February 28, 2019
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Sacral pressure injury After surgery check patient`s sacral skin condition After 1 hour surgery
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