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.
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.
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.
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
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.