Lower Eyelid Entropion Clinical Trial
Official title:
A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00842764 -
Minimally Invasive Holmium:YAG Laser Blepharoplasty
|
N/A |