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

Not Applicable

Completed

• Conditions: Lower Eyelid Entropion
• Interventions: Procedure: 5/0 vicryl test suture; Procedure: 7/0 vicryl suture

• Registration Number: NCT01598376
• Lead Sponsor: The Royal Bournemouth Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Study First Posted: 2012-05-15
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5/0 gauge vicryl suture	5/0 vicryl test suture	Patients randomly assigned to 5/0 gauge test everting suture
7/0 gauge vicryl suture	7/0 vicryl suture	Patients randomly assigned to 7/0 gauge test everting suture

Primary Outcome Measures

Name	Time	Method
Suture associated granuloma outer diameter	28 days	Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma central cellular element diameter	28 days	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	28 days	Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
Suture associated granuloma giant cell number	28 days	Count of giant cells on average of 6 histological sections from excised eyelid specimens

Trial Locations

Locations (1)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, Dorset, United Kingdom