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NCT00830271 Clinical Trial

Vicryl Plus and Monocryl Plus in Breast Surgery

Breast Cancer Surgery Clinical Trial

Official title:
Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00830271
Other study ID # C624/07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2008
Est. completion date April 2011

Study information
Verified date January 2009
Source Cardiff and Vale University Health Board
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vicryl plus and Monocryl plus
closure of skin and subcutaneous tissues
• wound closure with Vicryl and Monocryl
wound closure skin and subcutaneous tissues

Locations
Country Name City State
United Kingdom Cardiff and Vale NHS Trust Cardiff Wales

Sponsors (1)
Lead Sponsor Collaborator
Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary reduction of surgical site infection 6-7 months
Secondary estimation time in hospital and return to work numbers of haematomas and seromas 6-9 months
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