Vicryl Plus and Monocryl Plus in Breast Surgery

Not Applicable

Completed

• Conditions: Breast Cancer Surgery
• Interventions: Device: wound closure with Vicryl and Monocryl; Device: Vicryl plus and Monocryl plus

• Registration Number: NCT00830271
• Lead Sponsor: Cardiff and Vale University Health Board

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 available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vicryl/monocryl	wound closure with Vicryl and Monocryl	"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.
Vicryl plus/Monocryl plus	Vicryl plus and 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.

Primary Outcome Measures

Name	Time	Method
reduction of surgical site infection	6-7 months

Secondary Outcome Measures

Name	Time	Method
estimation time in hospital and return to work numbers of haematomas and seromas	6-9 months

Trial Locations

Locations (1)

Cardiff and Vale NHS Trust; 🇬🇧 Cardiff, Wales, United Kingdom