Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
This study has been completed.
Sponsor:
Ethicon, Inc.
Collaborator:
Johnson & Johnson Medical, China
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00768222
First received: October 7, 2008
Last updated: August 29, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Device: silk suture Device: VICRYL* Plus suture |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Ethicon, Inc.:
Primary Outcome Measures:
- Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) [ Time Frame: 30 days (+/- 5) post-operative ] [ Designated as safety issue: No ]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:
- Mean Cosmetic Outcome Score on Modified Hollander Scale [ Time Frame: 12 days ] [ Designated as safety issue: No ]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 Cosmetic Outcome Score on Modified Hollander Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]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 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]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)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]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)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]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)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 12 ] [ Designated as safety issue: Yes ]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)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]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)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]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)
| Enrollment: | 101 |
| Study Start Date: | October 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Device: silk suture
skin closure
Other Name: surgical suture (silk)
|
|
Experimental: 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
|
Device: VICRYL* Plus suture
skin closure
Other Names:
|
Detailed Description:
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768222
Locations
| China | |
| 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 | |
| Shanghai Jiao Tong Univ. affiliated Ruijin Hospital | |
| Shanghai, China | |
| Fudan Univ. affiliated Zhongshan Hospital | |
| Shanghai, China | |
Sponsors and Collaborators
Ethicon, Inc.
Johnson & Johnson Medical, China
Investigators
| Principal Investigator: | Zhongtao ZHANG, MD | Capital Medical University Affiliated Beijing Friendship Hospital |
More Information
No publications provided by Ethicon, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ethicon, Inc. |
| ClinicalTrials.gov Identifier: | NCT00768222 History of Changes |
| Other Study ID Numbers: | 200-08-002 |
| Study First Received: | October 7, 2008 |
| Results First Received: | June 27, 2011 |
| Last Updated: | August 29, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Ethicon, Inc.:
|
wound healing |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Anti-Bacterial Agents Triclosan Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 22, 2013