跳至主要内容
临床试验/NCT04724512
NCT04724512暂停4 期

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

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
4 期
状态
暂停
入组人数
44
试验地点
2
主要终点
diameter of the inflammatory reaction around the suture material

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • Unable to provide informed consent No one will be unfairly excluded/included in the research

结局指标

主要结局

diameter of the inflammatory reaction around the suture material

时间窗: 6 months post operation

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验