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

NCT04724512 | Suspended Phase 4

• 1 other identifier: 18SM4898
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Entropion; Inflammation in the Eyelid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

polypropylene

ACTIVE COMPARATOR

patients randomised to receive polypropylene sutures.

Device: suture

polyglactin

ACTIVE COMPARATOR

patients randomised to receive polyglactin sutures.

Device: suture

Interventions

suture DEVICE

a type of suture used in entropion surgery

polyglactin; polypropylene

Eligibility Criteria

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

You may qualify if:

• Adult patients (aged 18 years or over)
• Diagnosis of involutional entropion with sufficient lid laxity for a wedge excision
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Western Eye Hospital

London, NW1 5QH, United Kingdom

Location

Related Publications (1)

• Fayers T, Vekinis JS, Ah-Kye L, Parham D, Anketell P, Weir J, A'Hern R, Parkin B. Prospective randomised controlled trial to compare tissue reactions and scarring with polypropylene versus polyglactin 910 sutures in periocular skin. Br J Ophthalmol. 2025 Dec 12:bjo-2025-327724. doi: 10.1136/bjo-2025-327724. Online ahead of print.

  PMID: 41386795 DERIVED

MeSH Terms

Conditions

Entropion

Interventions

Sutures

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of different types of stitches to turn the eyelid outwards e.g. polypropylene Vs polyglactin 910 to establish if there is a difference in the level of post-operative inflammation.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: October 25, 2021
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)