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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer Surgery
 Device: Vicryl plus and Monocryl plus
Device: wound closure with Vicryl and Monocryl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:
  • reduction of surgical site infection [ Time Frame: 6-7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • estimation time in hospital and return to work numbers of haematomas and seromas [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830271

Locations
United Kingdom
Cardiff and Vale NHS Trust
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff and Vale University Health Board
  More Information

No publications provided

Responsible Party: Professor David Leaper, Cardiff University/Cardiff and Vale NHS Trust
ClinicalTrials.gov Identifier: NCT00830271     History of Changes
Other Study ID Numbers: C624/07
Study First Received: January 21, 2009
Last Updated: January 26, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cardiff and Vale University Health Board:
surgical site infection
wound complications
suture
antiseptic
wound closure

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 18, 2012