Self-adherent Wrap Techniques for Orbital Surgery

Not Applicable

Completed

• Conditions: Surgery; Eye Diseases
• Interventions: Other: Folded technique of self-adherent wrap; Other: Classic technique of self-adherent wrap

• Registration Number: NCT03415490
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2018-01-18
• Study Start: 2018-01-19
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Status Verified: 2018-04
• Primary Completion: 2018-04-21
• Study Completion: 2018-04-21
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folded technique of self-adherent wrap	Folded technique of self-adherent wrap	1. over 16 years old 2. free of any symptoms in the eyes 3. folded technique of self-adherent wrap after surgery
Classic technique of self-adherent wrap	Classic technique of self-adherent wrap	1. over 16 years old 2. free of any symptoms in the eyes 3. classic technique of self-adherent wrap after surgery

Primary Outcome Measures

Name	Time	Method
the pressure on the affected eye	10 minutes after bandage application in awake individuals	the pressure on the affected eye using the two methods

Secondary Outcome Measures

Name	Time	Method
the pressure outside the affected eye	10 minutes after bandage application in awake individuals	the pressure outside the affected eye using the two methods
discomfort scores	1 minute after recording the pressures	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.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China