Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

Ethicon

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Device: VICRYL* Plus suture; Device: silk suture

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768222

200-08-002

Details and patient eligibility

About

This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.

Full description

Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older with written informed consent
• Scheduled for a modified radical mastectomy
• Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification

Exclusion criteria

• Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
• Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
• Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification
• Has inflammatory cancers or skin ulceration
• Has known allergy or intolerance to triclosan
• Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse
• Has serious heart and/or lung disease
• Has skin scar history or family history
• Has direct relationship to or involvement in this or other studies under the direction of the investigator or center
• Received an experimental drug or device within 30 days prior to the planned start of treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Chinese Silk Suture

Active Comparator group

Description:

Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern

Treatment:

Device: silk suture

VICRYL* Plus Suture

Experimental group

Description:

Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique

Treatment:

Device: VICRYL* Plus suture