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Completed

NCT Number: NCT03415490

Self-adherent Wrap Techniques for Orbital Surgery

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

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Key information

Conditions

Surgery Eye Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any uncontrolled clinical problems

Treatment and study plan

Folded technique of self-adherent wrap

Other

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

Other

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.

Primary outcomes

  1. the pressure on the affected eye

    Time frame: 10 minutes after bandage application in awake individuals

    the pressure on the affected eye using the two methods

Secondary outcomes

  1. the pressure outside the affected eye

    Time frame: 10 minutes after bandage application in awake individuals

    the pressure outside the affected eye using the two methods

  2. discomfort scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2018
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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