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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ben Parkin, The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT01598376
First received: May 11, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Lower Eyelid Entropion
Procedure: 7/0 vicryl suture
Procedure: 5/0 vicryl test suture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • Suture associated granuloma outer diameter [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined

  • Suture associated granuloma central cellular element diameter [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined

  • Suture associated granuloma fibrous coat area [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined

  • Suture associated granuloma giant cell number [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Count of giant cells on average of 6 histological sections from excised eyelid specimens


Enrollment: 42
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598376

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: Ben Parkin, MD Royal Bournemouth Hospital
  More Information

No publications provided

Responsible Party: Ben Parkin, Consultant Ophthalmologist, The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT01598376     History of Changes
Other Study ID Numbers: RBH Suture Study
Study First Received: May 11, 2012
Last Updated: May 14, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
entropion
suture
granuloma
tissue reaction

Additional relevant MeSH terms:
Entropion
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014