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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic
outcome and surgical site infection.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)

Outcome Description:

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

Outcome Time Frame:

30 days (+/- 5) post-operative

Safety Issue:

No

Principal Investigator

Zhongtao ZHANG, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Capital Medical University Affiliated Beijing Friendship Hospital

Authority:

China: Food and Drug Administration

Study ID:

200-08-002

NCT ID:

NCT00768222

Start Date:

October 2008

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • wound healing
  • Breast Neoplasms

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