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

January 21, 2009
January 26, 2009
December 2008
July 2009   (final data collection date for primary outcome measure)
reduction of surgical site infection [ Time Frame: 6-7 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00830271 on ClinicalTrials.gov Archive Site
estimation time in hospital and return to work numbers of haematomas and seromas [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Vicryl Plus and Monocryl Plus in Breast Surgery
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer Surgery
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
September 2009
July 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00830271
C624/07
Yes
Professor David Leaper, Cardiff University/Cardiff and Vale NHS Trust
Cardiff and Vale University Health Board
Not Provided
Not Provided
Cardiff and Vale University Health Board
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP