Self-adherent Wrap Techniques for Orbital Surgery

Surgery Clinical Trial

Official title:

Folded and Classic Techniques of Self-adherent Wrap for Eyes After Orbital Tumour Extirpation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415490
• Other study ID #: 201801
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eye Diseases
• Surgery

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