A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin
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|ClinicalTrials.gov Identifier: NCT01598376|
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : May 15, 2012
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Lower Eyelid Entropion||Procedure: 7/0 vicryl suture Procedure: 5/0 vicryl test suture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
Active Comparator: 5/0 gauge vicryl suture
Patients randomly assigned to 5/0 gauge test everting suture
Procedure: 5/0 vicryl test suture
5/0 vicryl test suture placed as one of 3 everting sutures
Active Comparator: 7/0 gauge vicryl suture
Patients randomly assigned to 7/0 gauge test everting suture
Procedure: 7/0 vicryl suture
7/0 vicryl test suture placed as one of 3 everting sutures
- Suture associated granuloma outer diameter [ Time Frame: 28 days ]Histological measurement of suture associated granuloma outer diameter on excised eyelid specimens, average of 6 sections examined
- Suture associated granuloma central cellular element diameter [ Time Frame: 28 days ]Histological measurement of suture associated granuloma central cellular element diameter on excised eyelid specimens, average of 6 sections examined
- Suture associated granuloma fibrous coat area [ Time Frame: 28 days ]Histological measurement of suture associated granuloma fibrous coat area on excised eyelid specimens, average of 6 sections examined
- Suture associated granuloma giant cell number [ Time Frame: 28 days ]Count of giant cells on average of 6 histological sections from excised eyelid specimens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598376
|Royal Bournemouth Hospital|
|Bournemouth, Dorset, United Kingdom, BH7 7DW|
|Principal Investigator:||Ben Parkin, MD||Royal Bournemouth Hospital|