Vicryl Plus and Monocryl Plus in Breast Surgery

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Cardiff and Vale University Health Board

ClinicalTrials.gov Identifier:

NCT00830271

First received: January 21, 2009

Last updated: January 26, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 21, 2009
Last Updated Date	January 26, 2009
Start Date ^ICMJE	December 2008
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2009)	reduction of surgical site infection [ Time Frame: 6-7 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00830271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2009)	estimation time in hospital and return to work numbers of haematomas and seromas [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vicryl Plus and Monocryl Plus in Breast Surgery
Official Title ^ICMJE	Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
Brief Summary	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Breast Cancer Surgery
Intervention ^ICMJE	Device: Vicryl plus and Monocryl plus closure of skin and subcutaneous tissues Device: wound closure with Vicryl and Monocryl wound closure skin and subcutaneous tissues
Study Arm (s)	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. Intervention: Device: Vicryl plus and Monocryl plus Placebo Comparator: vicryl/monocryl "Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control. Intervention: Device: wound closure with Vicryl and Monocryl
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	September 2009
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00830271
Other Study ID Numbers ^ICMJE	C624/07
Has Data Monitoring Committee	Yes
Responsible Party	Professor David Leaper, Cardiff University/Cardiff and Vale NHS Trust
Study Sponsor ^ICMJE	Cardiff and Vale University Health Board
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cardiff and Vale University Health Board
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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