CClinicalTrials.gg
CompletedNCT03415490Updated May 2, 2018

Self-adherent Wrap Techniques for Orbital Surgery

An interventional study of Folded technique of self-adherent wrap and Classic technique of self-adherent wrap in Surgery and Eye Diseases, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Surgery
  • Eye Diseases

Browse trials for

Keywords

  • general anesthesia
  • self-adherent wrap
  • pressure
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • any uncontrolled clinical problems
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
128 participants (actual)

Study arms

  • Active comparator
    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

    Other: Classic technique of self-adherent wrap

  • Experimental
    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

    Other: Folded technique of self-adherent wrap

Interventions

  • OtherFolded 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

  • OtherClassic 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.

05

What researchers measure

Primary outcomes

  1. the pressure on the affected eye

    the pressure on the affected eye using the two methods

    Time frame: 10 minutes after bandage application in awake individuals

Secondary outcomes

  1. the pressure outside the affected eye

    the pressure outside the affected eye using the two methods

    Time frame: 10 minutes after bandage application in awake individuals

  2. 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.

    Time frame: 1 minute after recording the pressures

06

Study locations

1 site
  • Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03415490
Lead sponsor
Sun Yat-sen University
Responsible party
Huijing Ye (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Jan 30, 2018
Start date
Jan 19, 2018
Primary completion
Apr 21, 2018
Completion
Apr 21, 2018
Last update
May 2, 2018

Study contacts

Huijing Ye Ye
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion