Self-adherent Wrap Techniques for Orbital Surgery

NCT03415490 | Completed DMC

• 1 other identifier: 201801
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Eye Diseases

Keywords

general anesthesia; self-adherent wrap; pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the pressure outside the affected eye

  10 minutes after bandage application in awake individuals

• discomfort scores

  1 minute after recording the pressures

Study Arms (2)

Classic technique of self-adherent wrap

ACTIVE COMPARATOR

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

Folded technique of self-adherent wrap

EXPERIMENTAL

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

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

Folded technique of self-adherent wrap

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.

Classic technique of self-adherent wrap

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• any uncontrolled clinical problems

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Huijing Ye Ye

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 30, 2018
• Study Start: January 19, 2018
• Primary Completion: April 21, 2018
• Study Completion: April 21, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)