Skip to main content
OpenTrials
Completed

NCT Number: NCT01598376

A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin

Objective

To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response.

Design

A prospective, double blind, randomized clinical trial using a novel ethical study design. Both the patient and clinician analyzing the histology were blinded to the suture gauge used.

Participants

A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study.

Intervention

Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. After 28 days, entropion correction was achieved by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture.

Main outcome measure

Defined histological parameters of suture-related granulomas were measured at multiple levels. Data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Eyelid Entropion Entropion Eye Diseases Eyelid Diseases Granuloma Hemic and Lymphatic Diseases Lymphatic Diseases Lymphoproliferative Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients
  • Involutional lower eyelid entropion
  • Horizontal eyelid laxity associated
  • Informed consent

Exclusion criteria

  • Inability to provide informed consent
  • Previous eyelid surgery
  • Poorly controlled diabetes
  • Oral steroid use
  • Addisons disease

Treatment and study plan

7/0 vicryl suture

Procedure

7/0 vicryl test suture placed as one of 3 everting sutures

5/0 vicryl test suture

Procedure

5/0 vicryl test suture placed as one of 3 everting sutures

Primary outcomes

  1. Suture associated granuloma outer diameter

    Time frame: 28 days

    Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined

  2. Suture associated granuloma central cellular element diameter

    Time frame: 28 days

    Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined

  3. Suture associated granuloma fibrous coat area

    Time frame: 28 days

    Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined

  4. Suture associated granuloma giant cell number

    Time frame: 28 days

    Count of giant cells on average of 6 histological sections from excised eyelid specimens

Sponsors and collaborators

Lead sponsor

The Royal Bournemouth Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 15, 2012
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.