NCT03557489

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer

Interventions

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

Timeline

• Start date: 2018-06-16
• Primary completion: 2018-12-15
• Completion: 2019-02-28
• First posted: 2018-06-15
• Last updated: 2018-06-15