NCT00830271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2009

Enrollment Period

2.3 years

First QC Date

January 21, 2009

Last Update Submit

January 28, 2020

Conditions

Breast Cancer Surgery

Keywords

surgical site infectionwound complicationssutureantisepticwound closure

Outcome Measures

Primary Outcomes (1)

  • reduction of surgical site infection

    6-7 months

Secondary Outcomes (1)

  • estimation time in hospital and return to work numbers of haematomas and seromas

    6-9 months

Study Arms (2)

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

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

Interventions

Vicryl plus and Monocryl plusDEVICE

closure of skin and subcutaneous tissues

Vicryl plus/Monocryl plus
wound closure with Vicryl and MonocrylDEVICE

wound closure skin and subcutaneous tissues

vicryl/monocryl

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff and Vale NHS Trust

Cardiff, Wales, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 27, 2009

Study Start

December 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 30, 2020

Record last verified: 2009-01

Locations

GB(1)