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

T

Taipei Medical University

Status

Unknown

Conditions

Pressure Ulcer

Treatments

Device: Mepilex Border Sacrum

Study type

Interventional

Funder types

Other

Identifiers

NCT03557489
107HCP-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No 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

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Chun Mah, MS

Data sourced from clinicaltrials.gov

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