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Completed

NCT Number: NCT00830271

Vicryl Plus and Monocryl Plus in Breast Surgery

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.

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Key information

Conditions

Breast Cancer Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and Vale NHS Trust

Cardiff, Wales, CF14 4XN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vicryl plus and Monocryl plus

Device

closure of skin and subcutaneous tissues

wound closure with Vicryl and Monocryl

Device

wound closure skin and subcutaneous tissues

Primary outcomes

  1. reduction of surgical site infection

    Time frame: 6-7 months

Secondary outcomes

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

    Time frame: 6-9 months

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Official study title

Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2009
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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