SUSY Study (SUture StudY) Comparing Scarring With Polypropylene vs Polyglactin 910 Sutures
NCT ID: NCT04724512
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
44 participants
INTERVENTIONAL
2021-10-25
2024-10-31
Brief Summary
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There are several options for surgical management of entropion. One of the quickest and simplest treatments to turn the eyelid outwards is to have three stitches ('everting sutures') placed into the eyelid. However recurrence of the entropion is common following this procedure alone. A more permanent operation ('definitive surgery') is to shorten and tighten the eyelid ('wedge excision') in addition to the everting sutures. One approach is to perform the everting sutures soon after the patient attends, as this procedure can be done in a clinic or minor operations theatre and provides immediate relief of symptoms, followed by the wedge excision at a later date, when a slot is available in the operating theatre (which has a longer waiting list). These procedures are routinely offered to patients at our hospital.
Different surgeons use different types of stitches to turn the eyelid outwards e.g. polypropylene or polyglactin 910. Currently, there is no consensus as to which stitch causes less inflammation in the eyelid. The aim of this research study is to compare the inflammatory reaction between the two types of stitches. If there is a significant difference, this could provide useful information for surgeons in deciding which stitch is more appropriate for patients, especially those prone to scarring. We will assess the outcome of each type of stitch in terms of objective and clinical assessment of any scars (through questionnaires) and amount of inflammation caused (through examination of the tissue in the lab).
Detailed Description
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Recruitment Patients will be recruited from the oculoplastic clinics at the Western Eye Hospital and Royal Bournemouth Hospital where they will be approached by the principal investigator and colleagues who are also members of the regular care team and GCP trained. Patients will be informed about the study and given sufficient time to decide whether or not they wish to participate. Fully informed consent will be obtained before any study procedures will take place.
INCLUSION CRITERIA
* Adult patients (aged 18 years or over)
* Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
* Ability to provide informed consent EXCLUSION CRITERIA
* Aged under 18 years
* Prior lower eyelid surgery
* Predisposing conditions and treatments known to interfere with scarring and healing
* Concurrent steroid treatment
* Addison's disease
* Poorly controlled diabetes
* History of keloid scarring
* History or current cicatrizing disease
* Warfarin
* Unable to provide informed consent No one will be unfairly excluded/included in the research
Consent Consent will be taken by a researcher who is able to assess capacity and does so in everyday practice. Only participants who are able to give fully informed consent will be approached for participation.
Risks:
The suture material being studied are widely used in oculoplastic surgery internationally and within the NHS. All sutures can cause scarring, although the risk of significant scarring in eyelid surgery is low as eyelids tend to heal well due to a good blood supply. The main risk of surgery is that the procedure does not work, but these are standard NHS treatments and are accepted as being low risk. Patients will be informed that a benefit of being in the trial is that their procedure will be performed by a senior oculoplastic surgeon and much sooner than is usually possible on a standard NHS waiting list. They will have more close attention paid to their symptoms and a more detailed assessment and aftercare.
Confidentiality The investigators will abide by the Caldicott principles. Confidentiality will be maintained at all times in compliance with the ICH GCP and applicable Trust protocols.
Conflict of Interest There is no financial or other conflicts of interest. This is an investigator-led study. Ethicon are providing funding for the study but they have not been involved in the study design and will have no rights over the data handling or publication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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polypropylene
patients randomised to receive polypropylene sutures.
suture
a type of suture used in entropion surgery
polyglactin
patients randomised to receive polyglactin sutures.
suture
a type of suture used in entropion surgery
Interventions
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suture
a type of suture used in entropion surgery
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
* Ability to provide informed consent
Exclusion Criteria
* Prior lower eyelid surgery
* Predisposing conditions and treatments known to interfere with scarring and healing
* Concurrent steroid treatment
* Addison's disease
* Poorly controlled diabetes
* History of keloid scarring
* History or current cicatrizing disease
* Warfarin
* Unable to provide informed consent No one will be unfairly excluded/included in the research
18 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Locations
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Western Eye Hospital
London, , United Kingdom
Countries
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Other Identifiers
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18SM4898
Identifier Type: -
Identifier Source: org_study_id