A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
NCT ID: NCT01598376
Last Updated: 2012-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2010-06-30
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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5/0 gauge vicryl suture
Patients randomly assigned to 5/0 gauge test everting suture
5/0 vicryl test suture
5/0 vicryl test suture placed as one of 3 everting sutures
7/0 gauge vicryl suture
Patients randomly assigned to 7/0 gauge test everting suture
7/0 vicryl suture
7/0 vicryl test suture placed as one of 3 everting sutures
Interventions
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7/0 vicryl suture
7/0 vicryl test suture placed as one of 3 everting sutures
5/0 vicryl test suture
5/0 vicryl test suture placed as one of 3 everting sutures
Eligibility Criteria
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Inclusion Criteria
* Involutional lower eyelid entropion
* Horizontal eyelid laxity associated
* Informed consent
Exclusion Criteria
* Previous eyelid surgery
* Poorly controlled diabetes
* Oral steroid use
* Addisons disease
18 Years
ALL
No
Sponsors
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The Royal Bournemouth Hospital
OTHER
Responsible Party
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Ben Parkin
Consultant Ophthalmologist
Principal Investigators
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Ben Parkin, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Locations
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Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Countries
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Other Identifiers
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RBH Suture Study
Identifier Type: -
Identifier Source: org_study_id
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