Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Wounds and Injuries

Symptoms and General Pathology

Breast Neoplasms

Communicable Diseases

Surgical Wound Infection

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Lipid Regulating Agents

Anti-Bacterial Agents

Triclosan

Anti-Infective Agents, Local

Hypolipidemic Agents

Antimetabolites

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

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

silk suture

VICRYL* Plus suture

Zhongtao ZHANG, MD

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.

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

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

Pilot Evaluation of Cosmetic Outcome and Surgical Site Infection Rates of Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar

Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance

Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

Johnson & Johnson Medical, China

Ethicon, Inc.

Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.

Spots Global Cancer Trial Database for Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

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Conditions

Interventions

Study Description

Keywords

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