Phase 4 N=101 Randomized Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00768222 ↗

Enrolled (actual)

101

Serious AEs

4.0%

Results posted

Aug 2011

Primary outcome: Primary: Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) — 45.4; 67.2 score on scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: silk suture (Device); VICRYL* Plus suture (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon, Inc.
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)	45.4; 67.2	—
SECONDARY Mean Cosmetic Outcome Score on Modified Hollander Scale	5.0; 5.7	—
SECONDARY Mean Cosmetic Outcome Score on Modified Hollander Scale	5.0; 5.7	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—
SECONDARY Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3; 3.2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00768222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.