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

May 14, 2012 updated by: Ben Parkin, The Royal Bournemouth Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5/0 gauge vicryl suture
Patients randomly assigned to 5/0 gauge test everting suture
Procedure: 5/0 vicryl test suture
5/0 vicryl test suture placed as one of 3 everting sutures
Active Comparator: 7/0 gauge vicryl suture
Patients randomly assigned to 7/0 gauge test everting suture
Procedure: 7/0 vicryl suture
7/0 vicryl test suture placed as one of 3 everting sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days
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
28 days
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
28 days
Suture associated granuloma giant cell number
Time Frame: 28 days
Count of giant cells on average of 6 histological sections from excised eyelid specimens
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Bournemouth Hospital

Investigators

  • Principal Investigator: Ben Parkin, MD, Royal Bournemouth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBH Suture Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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