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| Name | Class |
|---|---|
| Johnson & Johnson Medical, China | INDUSTRY |
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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.
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Silk Suture | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silk suture | Device | skin closure |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongtao ZHANG, MD | Capital Medical University Affiliated Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical Univ. affiliated Hospital | Beijing | China | ||||
| Jilin Univ. affiliated Second Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21518565 | Derived | Zhang ZT, Zhang HW, Fang XD, Wang LM, Li XX, Li YF, Sun XW, Carver J, Simpkins D, Shen J, Weisberg M. Cosmetic outcome and surgical site infection rates of antibacterial absorbable (Polyglactin 910) suture compared to Chinese silk suture in breast cancer surgery: a randomized pilot research. Chin Med J (Engl). 2011 Mar;124(5):719-24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chinese 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chinese 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 |
| BG001 | VICRYL* Plus Suture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | 30 days (+/- 5) post-operative |
|
Intraoperative through 90 days post-operative
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chinese 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep incisional SSI | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaowei SUN, MD PhD | J&J Medical, China Ltd. | 86 10 5952 3103 | xsun5@its.jnj.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| VICRYL* Plus suture | Device | skin closure |
|
|
| 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 |
| Changchun |
| China |
| Dalian Medical Univ. affiliated first Hospital | Dalian | China |
| First Affiliated Hospital, Sun Yat-sen Univ. | Guangzhou | China |
| Fudan Univ. affiliated Zhongshan Hospital | Shanghai | China |
| Shanghai Jiao Tong Univ. affiliated Ruijin Hospital | Shanghai | China |
| Protocol Violation |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
|
|
| Secondary | 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 | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | 12 days |
|
|
|
| Secondary | 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 | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | 30 days |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 3 |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 5 |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 7 |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 12 |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 30 |
|
|
|
| Secondary | 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) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | score on scale | Day 90 |
|
|
|
| 3 |
| 50 |
| 14 |
| 50 |
| EG001 | 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 | 1 | 51 | 7 | 51 |
| Allergic shock | General disorders | Systematic Assessment |
|
| Skin lymphangitis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bone marrow suppression | Blood and lymphatic system disorders | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |