Back to resultsSelf-adherent Wrap Techniques for Orbital Surgery
Primary Purpose
Surgery, Eye Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Folded technique of self-adherent wrap
Classic technique of self-adherent wrap
Sponsored by
About this trial
This is an interventional supportive care trial for Surgery focused on measuring general anesthesia, self-adherent wrap, pressure
Eligibility Criteria
Inclusion Criteria:
- over 16 years old
- diagnosed as orbital disease or ocular tumor
- surgery under general anesthesia
Exclusion Criteria:
- any uncontrolled clinical problems
Sites / Locations
- Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classic technique of self-adherent wrap
Folded technique of self-adherent wrap
Arm Description
over 16 years old free of any symptoms in the eyes classic technique of self-adherent wrap after surgery
over 16 years old free of any symptoms in the eyes folded technique of self-adherent wrap after surgery
Outcomes
Primary Outcome Measures
the pressure on the affected eye
the pressure on the affected eye using the two methods
Secondary Outcome Measures
the pressure outside the affected eye
the pressure outside the affected eye using the two methods
discomfort scores
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.
Full Information
NCT ID
NCT03415490
First Posted
January 18, 2018
Last Updated
April 30, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03415490
Brief Title
Self-adherent Wrap Techniques for Orbital Surgery
Official Title
Folded and Classic Techniques of Self-adherent Wrap for Eyes After Orbital Tumour Extirpation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
April 21, 2018 (Actual)
Study Completion Date
April 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the interface pressure measurements of applying self-adherent wraps on eyes after orbital tumour extirpation.
Detailed Description
The purpose of this study is to evaluate the interface pressure measurements of the folded and classic techniques of applying self-adherent wraps on eyes after orbital tumour extirpation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Eye Diseases
Keywords
general anesthesia, self-adherent wrap, pressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classic technique of self-adherent wrap
Arm Type
Active Comparator
Arm Description
over 16 years old
free of any symptoms in the eyes
classic technique of self-adherent wrap after surgery
Arm Title
Folded technique of self-adherent wrap
Arm Type
Experimental
Arm Description
over 16 years old
free of any symptoms in the eyes
folded technique of self-adherent wrap after surgery
Intervention Type
Other
Intervention Name(s)
Folded technique of self-adherent wrap
Intervention Description
Wrapping a piece of self-adherent wrap around the patient's head starting with the opened end on the forehead above the affected eye.The bandage is then firmly but not tightly wrapped around the head twice. Then, after the second circuit, the bandage is brought on the cheek and up over the eye to the forehead, where it was passed between the eyebrows but not wrapped around the head. Instead, the bandage is folded and then first passed back on the cheek of the affected side then back to the forehead a total of four times. Finally, the bandage is wrapped completely around the head once
Intervention Type
Other
Intervention Name(s)
Classic technique of self-adherent wrap
Intervention Description
Wrapping a piece of self-adherent wrap around the patient's head starting with the opened end on the forehead above the affected eye.The bandage is then firmly but not tightly wrapped around the head twice. After the second circuit, the bandage was brought below the ear, up over the eye and around the head of the non-affected side and then wrapped around the head in the same manner four times. The bandage is then brought around the head once.
Primary Outcome Measure Information:
Title
the pressure on the affected eye
Description
the pressure on the affected eye using the two methods
Time Frame
10 minutes after bandage application in awake individuals
Secondary Outcome Measure Information:
Title
the pressure outside the affected eye
Description
the pressure outside the affected eye using the two methods
Time Frame
10 minutes after bandage application in awake individuals
Title
discomfort scores
Description
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.
Time Frame
1 minute after recording the pressures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over 16 years old
diagnosed as orbital disease or ocular tumor
surgery under general anesthesia
Exclusion Criteria:
any uncontrolled clinical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijing Ye Ye
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-adherent Wrap Techniques for Orbital Surgery
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