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

The Royal Bournemouth Hospital

Status: Completed

Conditions: Lower Eyelid Entropion

Treatments: Procedure: 5/0 vicryl test suture; Procedure: 7/0 vicryl suture

Study type: Interventional

Funder types: Other

Identifiers

NCT01598376

RBH Suture Study

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

5/0 gauge vicryl suture

Active Comparator group

Description:

Patients randomly assigned to 5/0 gauge test everting suture

Treatment:

Procedure: 5/0 vicryl test suture

7/0 gauge vicryl suture

Active Comparator group

Description:

Patients randomly assigned to 7/0 gauge test everting suture

Treatment:

Procedure: 7/0 vicryl suture