Vicryl Plus and Monocryl Plus in Breast Surgery

Cardiff and Vale University Health Board

Status: Completed

Conditions: Breast Cancer Surgery

Treatments: Device: wound closure with Vicryl and Monocryl; Device: Vicryl plus and Monocryl plus

Study type: Interventional

Funder types: Other

Identifiers

NCT00830271

C624/07

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Vicryl plus/Monocryl plus

Experimental group

Description:

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.

Treatment:

Device: Vicryl plus and Monocryl plus

vicryl/monocryl

Placebo Comparator group

Description:

"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.

Treatment:

Device: wound closure with Vicryl and Monocryl