Self-adherent Wrap Techniques for Orbital Surgery

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03415490
Collaborator
(none)
128
1
2
3
42.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Folded technique of self-adherent wrap
  • Other: Classic technique of self-adherent wrap
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Folded and Classic Techniques of Self-adherent Wrap for Eyes After Orbital Tumour Extirpation
Actual Study Start Date :
Jan 19, 2018
Actual Primary Completion Date :
Apr 21, 2018
Actual Study Completion Date :
Apr 21, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. the pressure outside the affected eye [10 minutes after bandage application in awake individuals]

    the pressure outside the affected eye using the two methods

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • over 16 years old

  • diagnosed as orbital disease or ocular tumor

  • surgery under general anesthesia

Exclusion Criteria:
  • any uncontrolled clinical problems

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huijing Ye, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03415490
Other Study ID Numbers:
  • 201801
First Posted:
Jan 30, 2018
Last Update Posted:
May 2, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huijing Ye, Principal Investigator, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2018