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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Device: silk suture; Device: VICRYL* Plus suture

• Registration Number: NCT00768222
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Results First Submitted: 2011-06-27
• Results First Submitted QC: 2011-07-27
• Status Verified: 2011-08
• Results First Posted: 2011-08-25
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Silk Suture	silk suture	Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
VICRYL* Plus Suture	VICRYL* Plus suture	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

Primary Outcome Measures

Name	Time	Method
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)	30 days (+/- 5) post-operative	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

Secondary Outcome Measures

Name	Time	Method
Mean Cosmetic Outcome Score on Modified Hollander Scale	30 days	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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	Day 90	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)

Trial Locations

Locations (6)

Jilin Univ. affiliated Second Hospital; 🇨🇳 Changchun, China

Dalian Medical Univ. affiliated first Hospital; 🇨🇳 Dalian, China

First Affiliated Hospital, Sun Yat-sen Univ.; 🇨🇳 Guangzhou, China

Shanghai Jiao Tong Univ. affiliated Ruijin Hospital; 🇨🇳 Shanghai, China

Capital Medical Univ. affiliated Hospital; 🇨🇳 Beijing, China

Fudan Univ. affiliated Zhongshan Hospital; 🇨🇳 Shanghai, China