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

Primary Purpose

Lower Eyelid Entropion

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
7/0 vicryl suture
5/0 vicryl test suture
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lower Eyelid Entropion focused on measuring entropion, suture, granuloma, tissue reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Bournemouth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5/0 gauge vicryl suture

7/0 gauge vicryl suture

Arm Description

Patients randomly assigned to 5/0 gauge test everting suture

Patients randomly assigned to 7/0 gauge test everting suture

Outcomes

Primary Outcome Measures

Suture associated granuloma outer diameter
Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma central cellular element diameter
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
Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma giant cell number
Count of giant cells on average of 6 histological sections from excised eyelid specimens

Secondary Outcome Measures

Full Information

First Posted
May 11, 2012
Last Updated
May 14, 2012
Sponsor
The Royal Bournemouth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01598376
Brief Title
A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
Official Title
A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Royal Bournemouth Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Eyelid Entropion
Keywords
entropion, suture, granuloma, tissue reaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5/0 gauge vicryl suture
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to 5/0 gauge test everting suture
Arm Title
7/0 gauge vicryl suture
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to 7/0 gauge test everting suture
Intervention Type
Procedure
Intervention Name(s)
7/0 vicryl suture
Intervention Description
7/0 vicryl test suture placed as one of 3 everting sutures
Intervention Type
Procedure
Intervention Name(s)
5/0 vicryl test suture
Intervention Description
5/0 vicryl test suture placed as one of 3 everting sutures
Primary Outcome Measure Information:
Title
Suture associated granuloma outer diameter
Description
Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
Time Frame
28 days
Title
Suture associated granuloma central cellular element diameter
Description
Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined
Time Frame
28 days
Title
Suture associated granuloma fibrous coat area
Description
Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
Time Frame
28 days
Title
Suture associated granuloma giant cell number
Description
Count of giant cells on average of 6 histological sections from excised eyelid specimens
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Parkin, MD
Organizational Affiliation
Royal Bournemouth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

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

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