Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03557489
Enrollment
210
Registered
2018-06-15
Start date
2018-06-16
Completion date
2019-02-28
Last updated
2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

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.

Interventions

DEVICEMepilex Border Sacrum

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

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sacral pressure injuryAfter 1 hour surgeryAfter surgery check patient's sacral skin condition

Contacts

Primary ContactChun Mah, MS
machun786@gmail.com886-2-22490088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026