Trial Outcomes & Findings for Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix (NCT NCT00566943)

Results Overview

Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

Discharge/ 30 days Linear Discharge/30/90 days Circular

Results posted on

2017-05-19

Participant Flow

Subjects were recruited at one surgical site in the US from approximately March 2006 through May 2008. One hundred one subjects were entered into the study.

Subjects were excluded from the study if their Body Mass Index was less than or equal to 35 or greater than or equal to 65. Subjects could not have a life expectancy of less than 12 months nor a known sensitivity to bovine material.

Participant milestones

Participant milestones
Measure	Control control arm where no buttress is used on stomach or GJ anastomosis staple lines.	PSD Veritas PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
Overall Study STARTED	52	49
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=52 Participants control arm where no buttress is used on stomach or GJ anastomosis staple lines.	PSD Veritas n=49 Participants PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.93 years STANDARD_DEVIATION 9.18 • n=5 Participants	46.61 years STANDARD_DEVIATION 10.2 • n=7 Participants	45.3 years STANDARD_DEVIATION 9.69 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	40 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	49 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: Discharge/ 30 days Linear Discharge/30/90 days Circular

Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.

Outcome measures

Outcome measures
Measure	Number of Subjects in Control Group n=52 Participants control arm where no buttress is used on stomach or GJ anastomosis staple lines.	Number of Subjects in PSD Veritas Group n=49 Participants PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Discharge/30 Linear Discharge/30/90 days Circular

Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.

Outcome measures

Outcome measures
Measure	Number of Subjects in Control Group n=52 Participants control arm where no buttress is used on stomach or GJ anastomosis staple lines.	Number of Subjects in PSD Veritas Group n=49 Participants PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Discharge and 30 days

Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.

Outcome measures

Outcome measures
Measure	Number of Subjects in Control Group n=26 Participants control arm where no buttress is used on stomach or GJ anastomosis staple lines.	Number of Subjects in PSD Veritas Group n=25 Participants PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group	10 Participants	6 Participants

SECONDARY outcome

Timeframe: Discharge, 30 and 90 days

Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.

Outcome measures

Outcome measures
Measure	Number of Subjects in Control Group n=26 Participants control arm where no buttress is used on stomach or GJ anastomosis staple lines.	Number of Subjects in PSD Veritas Group n=24 Participants PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.	1 participants	3 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PSD Veritas

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

Lesa Hobright-Turner, Director Clinical Affairs

Synovis Surgical Innovations

Phone: 651-796-7506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place