SurgeryNCT03415490
Self-adherent Wrap Techniques for Orbital Surgery
A study testing Folded technique of self-adherent wrap and Classic technique of self-adherent wrap in people with Surgery and Eye Diseases, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgery, Eye Diseases
- What is being tested?
- Folded technique of self-adherent wrap and Classic technique of self-adherent wrap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2018to 21 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- over 16 years old
- diagnosed as orbital disease or ocular tumor
- surgery under general anesthesia
Who cannot join
- any uncontrolled clinical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Folded and Classic Techniques of Self-adherent Wrap for Eyes After Orbital Tumour Extirpation
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.
- Conditions
- Surgery, Eye Diseases
- Being tested
- Folded technique of self-adherent wrap, Classic technique of self-adherent wrap
- Keywords
- general anesthesia, self-adherent wrap, pressure
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folded technique of self-adherent wrapOther
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 wrapOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Folded technique of self-adherent wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pressure on the affected eye
the pressure on the affected eye using the two methods
Measured: 10 minutes after bandage application in awake individuals
Secondary outcomes (2)
the pressure outside the affected eye
the pressure outside the affected eye using the two methods
Measured: 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.
Measured: 1 minute after recording the pressures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start19 Jan 2018
- Primary completion21 Apr 2018
- Study completion21 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijing Ye, Sun Yat-sen University
- Investigators
- Huijing Ye Ye, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415490
- Sponsor's protocol ID
- 201801
- Status last verified
- Apr 2018
- First submitted
- 18 Jan 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folded and Classic Techniques of Self-adherent Wrap for Eyes After Orbital Tumour Extirpation
- ClinicalTrials.gov ID
- NCT03415490
- Acronym / sponsor ID
- 201801
- Conditions
- Surgery, Eye Diseases
- Keywords
- general anesthesia, self-adherent wrap, pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 21 Apr 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic technique of self-adherent wrap | Active comparator | Other: Classic technique of self-adherent wrap1. over 16 years old 2. free of any symptoms in the eyes 3. classic technique of self-adherent wrap after surgery |
| Folded technique of self-adherent wrap | Experimental | Other: Folded technique of self-adherent wrap1. over 16 years old 2. free of any symptoms in the eyes 3. folded technique of self-adherent wrap after surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- over 16 years old
- diagnosed as orbital disease or ocular tumor
- surgery under general anesthesia
Key exclusion criteria (1 listed)
- any uncontrolled clinical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folded technique of self-adherent wrapWrapping 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 | Other | Folded technique of self-adherent wrap |
| Classic technique of self-adherent wrapWrapping 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. | Other | Classic technique of self-adherent wrap |
Primary outcome
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
2 secondary outcomes
the pressure outside the affected eye
Time frame: 10 minutes after bandage application in awake individuals
discomfort scores
Time frame: 1 minute after recording the pressures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huijing Ye Ye principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folded technique of self-adherent wrap and Classic technique of self-adherent wrap in people with Surgery and Eye Diseases, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pressure on the affected eye (time frame: 10 minutes after bandage application in awake individuals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.