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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
skin closure
skin closure
Capital Medical Univ. affiliated Hospital
Beijing, China
Jilin Univ. affiliated Second Hospital
Changchun, China
Dalian Medical Univ. affiliated first Hospital
Dalian, China
First Affiliated Hospital, Sun Yat-sen Univ.
Guangzhou, China
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
Time frame: 30 days (+/- 5) post-operative
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
Time frame: 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
Time frame: 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)
Time frame: Day 3
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
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Fudan Univ. affiliated Zhongshan Hospital
Shanghai, China
Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Shanghai, China
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 90