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

Study Overview
=================
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.

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

Conditions
-----------------
Lower Eyelid Entropion

Intervention / Treatment
-----------------
* Procedure: 7/0 vicryl suture
* Procedure: 5/0 vicryl test suture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suture associated granuloma outer diameter | 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 | 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 | 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 | Count of giant cells on average of 6 histological sections from excised eyelid specimens | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
entropion, suture, granuloma, tissue reaction