SUSY Study (SUture StudY) Comparing Scarring With Polypropylene vs Polyglactin 910 Sutures (SUSY)

Randomised Controlled Trial to Compare Tissue Reactions and Scarring With Polypropylene vs Polyglactin 910 Sutures in Periocular Skin: SUSY Study (SUture StudY)

Entropion is a common condition in which the ageing eyelid becomes lax and rolls inwards, resulting in the eyelashes rubbing against the surface of the eye. This can cause discomfort, excessive watering and in severe cases inflammation of the surface of the eye which may lead to permanent scarring and impairment of vision.

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).

Study Overview

• Status: Suspended
• Conditions: Entropion; Inflammation in the Eyelid
• Intervention / Treatment: Device: suture

Detailed Description

Purpose and design This study will be the first of its kind to address the difference in inflammatory reaction between these two sutures in entropion repair surgery. Both sutures are widely used in the NHS in eyelid surgery already. The study design has involved peer review from eminent doctors and two statisticians. The questionnaire development involved patients.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 5QH
    • Western Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: polypropylene; patients randomised to receive polypropylene sutures.	Device: suture; a type of suture used in entropion surgery
Active Comparator: polyglactin; patients randomised to receive polyglactin sutures.	Device: suture; a type of suture used in entropion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diameter of the inflammatory reaction around the suture material	The primary outcome measure will be histological, looking at the diameter of the inflammatory reaction around the suture material. In order to minimise the risk of bias from oblique sectioning of the histology, the smallest diameter recorded on each section will be used. Measurements will be taken at 6 levels within the tissue and the mean diameter will be recorded.	6 months post operation

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Eyelid Diseases; Inflammation; Entropion
• Other Study ID Numbers: 18SM4898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No