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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415490
Other study ID # 201801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2018
Est. completion date April 21, 2018

Study information

Verified date April 2018
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the interface pressure measurements of applying self-adherent wraps on eyes after orbital tumour extirpation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date April 21, 2018
Est. primary completion date April 21, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- over 16 years old

- diagnosed as orbital disease or ocular tumor

- surgery under general anesthesia

Exclusion Criteria:

- any uncontrolled clinical problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Folded technique of self-adherent wrap
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
Classic technique of self-adherent wrap
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.

Locations

Country Name City State
China Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the pressure on the affected eye the pressure on the affected eye using the two methods 10 minutes after bandage application in awake individuals
Secondary the pressure outside the affected eye the pressure outside the affected eye using the two methods 10 minutes after bandage application in awake individuals
Secondary 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. 1 minute after recording the pressures
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