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

Conditions

Breast Cancer

Keywords

wound healing

Brief 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.

Detailed description

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

Related papers

No related papers found yet.

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DEVICEsilk suture

skin closure

DEVICEVICRYL* Plus suture

skin closure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)	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

Secondary

Measure	Time frame	Description
Mean Cosmetic Outcome Score on Modified Hollander Scale	12 days	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	Day 3	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)

Countries

China

Participant flow

Participants by arm

Arm	Count
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	50
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	51
Total	101

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	1
Overall Study	Protocol Violation	0	2
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

Characteristic	Chinese Silk Suture	VICRYL* Plus Suture	Total
Age Continuous	52.2 years STANDARD_DEVIATION 10.3	53.0 years STANDARD_DEVIATION 12.1	52.6 years STANDARD_DEVIATION 11.2
Region of Enrollment China	50 participants	51 participants	101 participants
Sex: Female, Male Female	50 Participants	51 Participants	101 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	14 / 50	7 / 51
serious Total, serious adverse events	3 / 50	1 / 51

Outcome results

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

Time frame: 30 days (+/- 5) post-operative