Vicryl Plus and Monocryl Plus in Breast Surgery

January 28, 2020 updated by: Cardiff and Vale University Health Board

Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • Cardiff and Vale NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery

Exclusion Criteria:

  • patients unable to give consent or comply with follow up
  • patients undergoing surgery for benign disease
  • patients with inflammatory cancers or skin ulceration
  • patients having neo-adjuvant chemotherapy or radiotherapy
  • patients with known allergy to triclosan antiseptic
  • patients with immune deficiency diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vicryl plus/Monocryl plus
Vicryl plus and Monocryl plus is the active comparator arm. These are the "active" sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery.
Device: Vicryl plus and Monocryl plus
closure of skin and subcutaneous tissues
Placebo Comparator: vicryl/monocryl
"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.
Device: wound closure with Vicryl and Monocryl
wound closure skin and subcutaneous tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of surgical site infection
Time Frame: 6-7 months
6-7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
estimation time in hospital and return to work numbers of haematomas and seromas
Time Frame: 6-9 months
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff and Vale University Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C624/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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