Self-adherent Wrap Techniques for Orbital Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Eye Diseases

Intervention / Treatment
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* Other: Folded technique of self-adherent wrap
* Other: Classic technique of self-adherent wrap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 16 years old diagnosed as orbital disease or ocular tumor surgery under general anesthesia Exclusion Criteria: any uncontrolled clinical problems

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classic technique of self-adherent wrap<br>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<br>* 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.<br>|
| Experimental: Folded technique of self-adherent wrap<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anesthesia, self-adherent wrap, pressure