Trial Outcomes & Findings for Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery (NCT NCT00768222)

NCT ID: NCT00768222

Last Updated: 2011-08-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 101 participants
• Primary outcome timeframe: 30 days (+/- 5) post-operative
• Results posted on: 2011-08-31

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	50	51
Overall Study COMPLETED	46	47
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	3	1
Overall Study Protocol Violation	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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	Total n=101 Participants Total of all reporting groups
Age Continuous	52.2 years STANDARD_DEVIATION 10.3 • n=93 Participants	53.0 years STANDARD_DEVIATION 12.1 • n=4 Participants	52.6 years STANDARD_DEVIATION 11.2 • n=27 Participants
Sex: Female, Male Female	50 Participants n=93 Participants	51 Participants n=4 Participants	101 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment China	50 participants n=93 Participants	51 participants n=4 Participants	101 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days (+/- 5) post-operative

Population: Intention to treat (ITT)

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 measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)	45.4 score on scale Standard Deviation 12.0	67.2 score on scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: 12 days

Population: Intention to treat (ITT)

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

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Cosmetic Outcome Score on Modified Hollander Scale	5.2 score on scale Standard Deviation 1.2	5.7 score on scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 30 days

Population: Intention to treat (ITT)

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

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Cosmetic Outcome Score on Modified Hollander Scale	5.0 score on scale Standard Deviation 1.2	5.7 score on scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Day 3

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	1.6 score on scale Standard Deviation 1.3	1.2 score on scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Day 5

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	1.5 score on scale Standard Deviation 1.3	1.2 score on scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Day 7

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	1.4 score on scale Standard Deviation 1.3	0.9 score on scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Day 12

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.6 score on scale Standard Deviation 3.6	3.3 score on scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: Day 30

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.6 score on scale Standard Deviation 3.5	3.7 score on scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Day 90

Population: Intention to treat (ITT)

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)

Outcome measures

Measure	Chinese Silk Suture n=50 Participants Natural, 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 n=51 Participants 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
Mean Surgical Site Infection Score on Modified ASEPSIS Scale	4.3 score on scale Standard Deviation 3.3	3.2 score on scale Standard Deviation 3.6

Adverse Events

Chinese Silk Suture

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

VICRYL* Plus Suture

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chinese Silk Suture n=50 participants at risk Natural, 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 n=51 participants at risk 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
Skin and subcutaneous tissue disorders Deep incisional SSI	2.0% 1/50 • Number of events 1 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	0.00% 0/51 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.
General disorders Allergic shock	2.0% 1/50 • Number of events 1 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	0.00% 0/51 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.
Blood and lymphatic system disorders Skin lymphangitis	2.0% 1/50 • Number of events 1 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	0.00% 0/51 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.
Blood and lymphatic system disorders Bone marrow suppression	0.00% 0/50 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	2.0% 1/51 • Number of events 1 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.

Other adverse events

Measure	Chinese Silk Suture n=50 participants at risk Natural, 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 n=51 participants at risk 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
Infections and infestations Incision site infection	8.0% 4/50 • Number of events 4 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	3.9% 2/51 • Number of events 2 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.
Injury, poisoning and procedural complications Seroma	12.0% 6/50 • Number of events 6 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	9.8% 5/51 • Number of events 5 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.
Skin and subcutaneous tissue disorders Skin necrosis	8.0% 4/50 • Number of events 4 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.	0.00% 0/51 • Intraoperative through 90 days post-operative Investigators were required to report all adverse events to the sponsor within 24 hours of becoming aware of the event. Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning at each of the visits.

Additional Information

Xiaowei SUN, MD PhD

J&J Medical, China Ltd.

Phone: 86 10 5952 3103

Email: xsun5@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER