Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768222
• Other study ID #: 200-08-002
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2008
• Last updated: August 29, 2011
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2011
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• silk suture
skin closure
• VICRYL* Plus suture
skin closure

Locations

Country	Name	City	State
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	Fudan Univ. affiliated Zhongshan Hospital	Shanghai
China	Shanghai Jiao Tong Univ. affiliated Ruijin Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	Johnson & Johnson Medical, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 days (+/- 5) post-operative	No
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	12 days	No
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	30 days	No
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)	Day 3	Yes
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)	Day 5	Yes
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)	Day 7	Yes
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)	Day 12	Yes
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)	Day 30	Yes
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)	Day 90	Yes