Clinical trial · Interventional
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
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
NCT00768222CI-TRIAL-00005425completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| silk suture | Device | — | UNRESOLVED |
| VICRYL* Plus suture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chinese Silk Suture
- description
- Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
- interventionNames
- Device: silk suture
- type
- EXPERIMENTAL
- label
- VICRYL* Plus Suture
- description
- 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
- interventionNames
- Device: VICRYL* Plus suture
Primary outcomes (1)
- measure
- Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhang 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. PMID 21518565