Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
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.