Vicryl Plus and Monocryl Plus in Breast Surgery - Full Text View

Sponsored by:	Cardiff and Vale NHS Trust
Information provided by:	Cardiff and Vale NHS Trust
ClinicalTrials.gov Identifier:	NCT00830271

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 IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Poliglecaprone 25

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Further study details as provided by Cardiff and Vale NHS Trust:

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
Vicryl plus/Monocryl plus: Experimental 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
vicryl/monocryl: Placebo Comparator "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, Wales
Cardiff and Vale NHS Trust
Cardiff, Wales, United Kingdom, CF14 4XN

Sponsors and Collaborators

Cardiff and Vale NHS Trust

More Information

No publications provided

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

Keywords provided by Cardiff and Vale NHS Trust:

surgical site infection
wound complications
suture
antiseptic
wound closure

Study placed in the following topic categories:

Anti-Infective Agents, Local
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009