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

Lower Eyelid Entropion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598376
• Other study ID #: RBH Suture Study
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: May 14, 2012
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Entropion
• Lower Eyelid Entropion

Intervention

Procedure:
• 7/0 vicryl suture
7/0 vicryl test suture placed as one of 3 everting sutures
• 5/0 vicryl test suture
5/0 vicryl test suture placed as one of 3 everting sutures

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suture associated granuloma outer diameter	Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined	28 days	No
Primary	Suture associated granuloma central cellular element diameter	Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined	28 days	No
Primary	Suture associated granuloma fibrous coat area	Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined	28 days	No
Primary	Suture associated granuloma giant cell number	Count of giant cells on average of 6 histological sections from excised eyelid specimens	28 days	No