Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001258943
Ethics application status
Approved
Date submitted
15/06/2020
Date registered
24/11/2020
Date last updated
24/11/2020
Date data sharing statement initially provided
24/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laissez-faire vs direct closure in eyelid repair
Scientific title
A randomised control trial of laissez-faire (secondary intention healing) versus direct closure in full thickness lower eyelid defects following lesion excision surgery.
Secondary ID [1] 301454 0
None
Universal Trial Number (UTN)
U1111-1253-0248
Trial acronym
LF vs DC
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Lower eyelid defects 317770 0
Lower eyelid reconstruction 319304 0
Condition category
Condition code
Surgery 315837 315837 0 0
Surgical techniques
Eye 316241 316241 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After excision of lower lid lesions, cases that can be repaired by a direct closure technique will be randomised to direct closure with suturing of the wound ( the standard treatment)by one of the ophthalmologists in the research team in an operating theatre, or laissez-faire ( left to heal by secondary intention). This is the intervention, and only occurs once. This will be carried out in an ophthalmology clinic. The patient not have any sutures inserted in to the eyelid defect. No dressing will be applied. The patient will be given instructions on self care of the wound - by performing wound care to clean the eyelid as necessary with supplied materials & saline solutions. The patient will apply antibiotic ointment to the wound for several days. All patients will be seen & assessed again within 4-5 days of their initial tumour excision. Any additional interventions that are required will be recorded by one of the investigators at the post-operative visits.
Intervention code [1] 317766 0
Treatment: Surgery
Comparator / control treatment
The control treatment is the direct closure technique of a lower lid wound. This will be suturing to close the wound by one of the ophthalmologists in the research team in an operating theatre.

The surgery is a one-off procedure & will be performed in an operating theatre or an appropriately equipped procedure room. It will performed under local anaesthetic alone or under sedation (if required, intravenous or oral). The wound will be cleaned and draped. Then the wound will be sutured closed by one of the investigators ( an oculoplastic surgeon or a supervised ophthalmic surgeon-in training) using a standard direct closure technique. The wound is closed in layers using dissolving sutures for the deep layers & skin sutures to close the skin. After surgery is completed, the eye is padded or left open depending on the risk of bleeding or ocular irritation. The patient will be seen buy one of the investigators within 4-5 days to assess the wound, remove the sutures and to note any additional interventions that are required.
Control group
Active

Outcomes
Primary outcome [1] 325380 0
Presence or absence of corneal ulceration
Assessed by data linkage to customised data collection proformas.
Timepoint [1] 325380 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Primary outcome [2] 325383 0
Presence or absence of trichiasis
Assessed by data linkage to customised data collection proformas.
Timepoint [2] 325383 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Primary outcome [3] 325384 0
Presence or absence of entropion
Assessed by data linkage to customised data collection proformas
Timepoint [3] 325384 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [1] 387722 0
Additional Primary outcome: Presence or absence of lagophthalmos
Assessed by data linkage to customised data collection proformas
Timepoint [1] 387722 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [2] 387723 0
Additional Primary outcome: Presence or absence of eye discharge.
Assessed by data linkage to customised data collection proformas
Timepoint [2] 387723 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [3] 387724 0
Additional Primary outcome: Revision surgery
Assessed by data linkage to customised data collection proformas
Timepoint [3] 387724 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [4] 387725 0
Additional Primary outcome: Loss of Snellen visual acuity compared to baseline.
Measured on a Snellen visual acuity chart
Timepoint [4] 387725 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [5] 388996 0
Additional Primary outcome: presence or absence of lid notching
Assessed by data linkage to customised data collection proformas
Timepoint [5] 388996 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [6] 388997 0
Additional Primary outcome: presence or absence of lower lid retraction
Assessed by data linkage to customised data collection proformas
Timepoint [6] 388997 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [7] 388998 0
Additional Primary outcome: Increased tear break up time compared to baseline
Measured on an Anterior anterior segment multimodal imaging device
Timepoint [7] 388998 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [8] 388999 0
Additional Primary outcome: Medial & lateral cantonal tendon laxity
Assessed on a cantonal tendon laxity scale devised by Lee et al
Timepoint [8] 388999 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [9] 389000 0
Additional Primary outcome: Presence or absence of lower lid ectropion
Measured on the Moe & Linder ectropion grading scale
Timepoint [9] 389000 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [10] 389001 0
Additional Primary outcome: Patient satisfaction with the lid appearance
Assessed by data linkage to customised study- specific questionnaire
Timepoint [10] 389001 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [11] 389002 0
Additional Primary outcome: Patient reported ocular irritation & pain.
Assessed by data linkage to customised study-specific questionnaire
Timepoint [11] 389002 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [12] 389003 0
Additional Primary putcome: Patient reported watering from the eye
Assessed by data linkage to customised study-specific questionnaire
Timepoint [12] 389003 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [13] 389004 0
Additional Primary outcome: Patient- reported eye discharge
Assessed by data linkage to customised study-specific questionnaire
Timepoint [13] 389004 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)
Secondary outcome [14] 389005 0
Additional Primary outcome: patient reported quality of life.
Assessed by data linkage to customised study-specific questionnaire
Timepoint [14] 389005 0
Baseline, 4-5 days, 3 weeks & 3 months after intervention (primary time point)

Eligibility
Key inclusion criteria
Patients undergoing excision of lower lid lesions that result in defects that are able to be closed by a direct closure technique.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 20
Patients who decline to give consent
Patients unable to give consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone to Principal Investigator who will inform the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/01/2023
Actual
Sample size
Target
120
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 22658 0
New Zealand
State/province [1] 22658 0
Waikato & Canterbury

Funding & Sponsors
Funding source category [1] 305888 0
Hospital
Name [1] 305888 0
Waikato Hospital
Country [1] 305888 0
New Zealand
Funding source category [2] 306942 0
Hospital
Name [2] 306942 0
Christchurch Hospital
Country [2] 306942 0
New Zealand
Primary sponsor type
Individual
Name
Dr Stephen Ng
Address
Eye Department,
Waikato Hospital
P Bag 3200
Hamilton 3204
Country
New Zealand
Secondary sponsor category [1] 306344 0
Individual
Name [1] 306344 0
Dr Rebecca Stack
Address [1] 306344 0
Eye Department,
Christchurch Hospital,
PO Box 1600
Christchurch 8140
Country [1] 306344 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306149 0
New Zealand Health & Disability Ethics Committees (HDEC)
Ethics committee address [1] 306149 0
New Zealand Ministry of Health
HDEC
Po Box 5013
Wellington 6140
Ethics committee country [1] 306149 0
New Zealand
Date submitted for ethics approval [1] 306149 0
12/06/2020
Approval date [1] 306149 0
13/08/2020
Ethics approval number [1] 306149 0
20/CEN/131

Summary
Brief summary
Secondary intention healing, also known as laissez-faire, was first described in eyelid surgery in 1957. However, it is more common for surgical reconstruction to occur after skin lesion excision from the eyelids. There have been a few case series, advocating laissez-faire as a viable alternative treatment option with promising results that is not inferior to surgical reconstruction. The objective of this randomised control trial is to randomly assign cases that have had lower lid lesions removed to either Laissez-faire or surgical wound closure, and analyse the outcomes. We predict that there is no difference in outcome or at least no inferiority between Laissez-faire compared to primary direct closure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102878 0
Dr Stephen Ng
Address 102878 0
Eye Department
Waikato Hospital
P Bag 3200
Waikato Mail Centre
Hamilton 3240
Country 102878 0
New Zealand
Phone 102878 0
+64 211371484
Fax 102878 0
Email 102878 0
[email protected]
Contact person for public queries
Name 102879 0
Dr Stephen Ng
Address 102879 0
Eye Department
Waikato Hospital
P Bag 3200
Waikato Mail Centre
Hamilton 3240
Country 102879 0
New Zealand
Phone 102879 0
+64 211371484
Fax 102879 0
Email 102879 0
[email protected]
Contact person for scientific queries
Name 102880 0
Dr Stephen Ng
Address 102880 0
Eye Department
Waikato Hospital
P Bag 3200
Waikato Mail Centre
Hamilton 3240
Country 102880 0
New Zealand
Phone 102880 0
+64 211371484
Fax 102880 0
Email 102880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication with no end date
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval by Principal Investigator via email
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8804Ethical approval  [email protected] 379955-(Uploaded-11-10-2020-18-29-48)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.