Vicryl Plus and Monocryl Plus in Breast Surgery

NCT ID: NCT00830271

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Vicryl plus and Monocryl plus

Intervention Type DEVICE

closure of skin and subcutaneous tissues

vicryl/monocryl

"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.

Group Type PLACEBO_COMPARATOR

wound closure with Vicryl and Monocryl

Intervention Type DEVICE

wound closure skin and subcutaneous tissues

Interventions

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Vicryl plus and Monocryl plus

closure of skin and subcutaneous tissues

Intervention Type DEVICE

wound closure with Vicryl and Monocryl

wound closure skin and subcutaneous tissues

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiff and Vale NHS Trust

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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C624/07

Identifier Type: -

Identifier Source: org_study_id

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