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

NCT01598376 | Completed

• 1 other identifier: RBH Suture Study
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Eyelid Entropion

Keywords

entropion; suture; granuloma; tissue reaction

Outcome Measures

Primary Outcomes (4)

• Suture associated granuloma outer diameter

  Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined

  28 days

• 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

• 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

• Suture associated granuloma giant cell number

  Count of giant cells on average of 6 histological sections from excised eyelid specimens

  28 days

Study Arms (2)

5/0 gauge vicryl suture

ACTIVE COMPARATOR

Patients randomly assigned to 5/0 gauge test everting suture

Procedure: 5/0 vicryl test suture

7/0 gauge vicryl suture

ACTIVE COMPARATOR

Patients randomly assigned to 7/0 gauge test everting suture

Procedure: 7/0 vicryl suture

Interventions

7/0 vicryl suture PROCEDURE

7/0 vicryl test suture placed as one of 3 everting sutures

7/0 gauge vicryl suture

5/0 vicryl test suture PROCEDURE

5/0 vicryl test suture placed as one of 3 everting sutures

5/0 gauge vicryl suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients
• Involutional lower eyelid entropion
• Horizontal eyelid laxity associated
• Informed consent

You may not qualify if:

• Inability to provide informed consent
• Previous eyelid surgery
• Poorly controlled diabetes
• Oral steroid use
• Addisons disease

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Entropion; Granuloma

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Parkin, MD

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

GB (1)