Trial Outcomes & Findings for The neoClose Abdominal Closure vs Carter-Thomason Trial (NCT NCT02589171)

NCT ID: NCT02589171

Last Updated: 2019-08-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: at the time of surgery
• Results posted on: 2019-08-28

Participant Flow

Participant milestones

Measure	Neo Close Abdominal Closure Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device Carter Thomason Device: Carter Thomason Device
Overall Study STARTED	35	35
Overall Study Day 1 Follow up	35	35
Overall Study Week 1 Follow up	35	34
Overall Study Week 6 Follow up	28	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The neoClose Abdominal Closure vs Carter-Thomason Trial

Baseline characteristics by cohort

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=35 Participants Carter Thomason Device: Carter Thomason Device	Total n=70 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 12 • n=5 Participants	45 years STANDARD_DEVIATION 11 • n=7 Participants	46 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: at the time of surgery

Population: Data were not available for 4 in the NeoClose arm and 3 in the Carter Thomason arm.

Outcome measures

Measure	Neo Close Abdominal Closure n=31 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=32 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site	2 number of sutures Standard Deviation 0	1.84 number of sutures Standard Deviation 0.37

PRIMARY outcome

Timeframe: at the time of surgery

Population: Data were not available for 5 in the NeoClose arm and 6 in the Carter Thomason arm.

Outcome measures

Measure	Neo Close Abdominal Closure n=30 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=29 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site	2 number of sutures Standard Deviation 0	1.83 number of sutures Standard Deviation 0.38

PRIMARY outcome

Timeframe: at the time of surgery

Population: Data were not available for 1 in the Carter Thomason arm.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=34 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site	20.95 seconds Standard Deviation 11.73	33.23 seconds Standard Deviation 25.89

PRIMARY outcome

Timeframe: at the time of surgery

Population: Data were not available for 3 in the Carter Thomason arm.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=32 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site	18.49 seconds Standard Deviation 7.79	28.63 seconds Standard Deviation 11.41

PRIMARY outcome

Timeframe: at the time of surgery

Population: Data were not available for 12 participants in the NeoClose arm and 16 participants in the Carter Thomason arm. For each participant analyzed, there were needle depth data available for 1, 2, 3, or 4 stitches per participant.

Outcome measures

Measure	Neo Close Abdominal Closure n=80 stitch Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=74 stitch Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site	3.2 centimeters Standard Deviation 0.93	4.9 centimeters Standard Deviation 1.67

PRIMARY outcome

Timeframe: immediately post op

Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=35 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 week

Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=34 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

Outcome measures

Measure	Neo Close Abdominal Closure n=28 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=30 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Data were not available for 1 in the Carter Thomason arm.

Abdominal ultrasound will be used to detect port site hernia.

Outcome measures

Measure	Neo Close Abdominal Closure n=28 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=29 Participants Carter Thomason Device: Carter Thomason Device
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively	0 Participants	0 Participants

SECONDARY outcome

Timeframe: day 1

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=35 Participants Carter Thomason Device: Carter Thomason Device
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	0.66 units on a scale Standard Deviation 1.21	0.66 units on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: 1 week

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=34 Participants Carter Thomason Device: Carter Thomason Device
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	0.34 units on a scale Standard Deviation 0.84	0.74 units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: 6 weeks

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=28 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=30 Participants Carter Thomason Device: Carter Thomason Device
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	0 units on a scale Standard Deviation 0	0.07 units on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: day 1

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=35 Participants Carter Thomason Device: Carter Thomason Device
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	1.03 units on a scale Standard Deviation 1.89	1.00 units on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: 1 week

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=34 Participants Carter Thomason Device: Carter Thomason Device
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	0.40 units on a scale Standard Deviation 1.50	1.03 units on a scale Standard Deviation 1.60

SECONDARY outcome

Timeframe: 6 weeks

Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.

Outcome measures

Measure	Neo Close Abdominal Closure n=28 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=30 Participants Carter Thomason Device: Carter Thomason Device
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: week 1

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=34 Participants Carter Thomason Device: Carter Thomason Device
Pain as Assessed by Number of Participants Who Took Pain Medications	10 Participants	10 Participants

SECONDARY outcome

Timeframe: week 6

Outcome measures

Measure	Neo Close Abdominal Closure n=28 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=30 Participants Carter Thomason Device: Carter Thomason Device
Pain as Assessed by Number of Participants Who Took Pain Medications	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)

Outcome measures

Measure	Neo Close Abdominal Closure n=35 Participants Neo Close Abdominal Closure: Neo Close Abdominal Closure	Carter Thomason Device n=35 Participants Carter Thomason Device: Carter Thomason Device
Hospital Stay Duration	2.12 days Standard Deviation 0.57	2.12 days Standard Deviation 0.83

Adverse Events

Neo Close Abdominal Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carter Thomason Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor

The University of Texas Health Science Center at Houston

Phone: (713) 500-7277

Email: Shinil.K.Shah@uth.tmc.edu

Results disclosure agreements

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