Breast CancerPhase 4NCT00768222
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
A Phase 4 study testing silk suture and VICRYL* Plus suture in people with Breast Cancer, run by Ethicon, Inc. at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- silk suture and VICRYL* Plus suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2008to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Capital Medical Univ. affiliated Hospital
Beijing
Jilin Univ. affiliated Second Hospital
Changchun
Dalian Medical Univ. affiliated first Hospital
Dalian
First Affiliated Hospital, Sun Yat-sen Univ.
Guangzhou
Fudan Univ. affiliated Zhongshan Hospital
Shanghai
Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Shanghai
About this study
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
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.
Read the detailed description
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
- Conditions
- Breast Cancer
- Being tested
- silk suture, VICRYL* Plus suture
- Keywords
- wound healing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silk sutureDevice
Also called surgical suture (silk)
skin closure
VICRYL* Plus sutureDevice
Also called Polyglactin 910 (Vicryl), Triclosan (antibacterial)
skin closure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: silk suture |
| 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 Receives: Device: VICRYL* Plus suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days (+/- 5) post-operative
Secondary outcomes (8)
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Medical, China
- Responsible party
- Sponsor
- Investigators
- Zhongtao ZHANG, MD, Principal investigator, Capital Medical University Affiliated Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768222
- Sponsor's protocol ID
- 200-08-002
- Status last verified
- Aug 2011
- First submitted
- 7 Oct 2008
- Last updated
- 31 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21518565
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00768222
- Acronym / sponsor ID
- 200-08-002
- Conditions
- Breast Cancer
- Keywords
- wound healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Medical, China
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Posted 25 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Silk Suture | Active comparator | Device: silk sutureNatural, 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 | Device: VICRYL* Plus sutureSynthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silk sutureAlso: surgical suture (silk)skin closure | Device | Chinese Silk Suture |
| VICRYL* Plus sutureAlso: Polyglactin 910 (Vicryl), Triclosan (antibacterial)skin closure | Device | VICRYL* Plus Suture |
Primary outcome
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
Time frame: 30 days (+/- 5) post-operative
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
8 secondary outcomes
Mean Cosmetic Outcome Score on Modified Hollander Scale
Time frame: 12 days
Mean Cosmetic Outcome Score on Modified Hollander Scale
Time frame: 30 days
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 3
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 5
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 7
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 12
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 30
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21518565Zhang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongtao ZHANG, MD principal investigator
Capital Medical University Affiliated Beijing Friendship Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing silk suture and VICRYL* Plus suture in people with Breast Cancer, run by Ethicon, Inc. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) (time frame: 30 days (+/- 5) post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2011.