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

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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: silk suture
* Device: VICRYL* Plus suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chinese Silk Suture<br>Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern | Device: silk suture<br>* skin closure<br>* Other names: surgical suture (silk);|
| Experimental: VICRYL* Plus Suture<br>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 | Device: VICRYL* Plus suture<br>* skin closure<br>* Other names: Triclosan (antibacterial);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) | 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 | 30 days (+/- 5) post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Cosmetic Outcome Score on Modified Hollander Scale | 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 | 12 days | 
| Mean Cosmetic Outcome Score on Modified Hollander Scale | 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 | 30 days | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 3 | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 5 | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 7 | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 12 | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 30 | 
| Mean Surgical Site Infection Score on Modified ASEPSIS Scale | 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) | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing