NCT03557489

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 5, 2018

Last Update Submit

June 5, 2018

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Sacral pressure injury

    After surgery check patient's sacral skin condition

    After 1 hour surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Mepilex Border Sacrum

Control group

NO INTERVENTION

patients use gel pad(in usual) during surgery.

Interventions

Mepilex Border SacrumDEVICE

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

Experimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.

You may not qualify if:

  • under 20 years
  • Patients have any skin lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chun Mah, MS

    Deputy Director of Nursing Department in Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Mah, MS

CONTACT

886-2-22490088machun786@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Nursing Department

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 15, 2018

Study Start

June 16, 2018

Primary Completion

December 15, 2018

Study Completion

February 28, 2019

Last Updated

June 15, 2018

Record last verified: 2018-06