Self-adherent Wrap Techniques for Orbital Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Surgery
• Intervention / Treatment: Other: Classic technique of self-adherent wrap; Other: Folded technique of self-adherent wrap

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• over 16 years old
• diagnosed as orbital disease or ocular tumor
• surgery under general anesthesia

Exclusion Criteria:

• any uncontrolled clinical problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Classic technique of self-adherent wrap; over 16 years old; free of any symptoms in the eyes; classic technique of self-adherent wrap after surgery	Other: 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.
EXPERIMENTAL: Folded technique of self-adherent wrap; over 16 years old; free of any symptoms in the eyes; folded technique of self-adherent wrap after surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the pressure outside the affected eye	the pressure outside the affected eye using the two methods	10 minutes after bandage application in awake individuals
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Huijing Ye Ye, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2018
• Primary Completion (ACTUAL): April 21, 2018
• Study Completion (ACTUAL): April 21, 2018

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: pressure; general anesthesia; self-adherent wrap
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 201801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No