Trial Outcomes & Findings for Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery (NCT NCT00559013)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Discharge and 1 Month post surgery

Results posted on

2017-05-10

Participant Flow

38 subjects were recruited from two principal investigators and their respective surgical hospitals in the US from approximately February 2007 through October 2008.

Subjects were excluded from the study if the met any of the exclusion criteria including having a a body mass index greater than 35, a history of Chron's Disease, or stage IV cancer. There was no washout, run-in or transition period to this study.

Participant milestones

Participant milestones
Measure	PSD Veritas Collagen Matrix Reinforcement Arm Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PSD Veritas Collagen Matrix Reinforcement Arm n=38 Participants Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=39 Participants
Age, Categorical >=65 years	11 Participants n=39 Participants
Age, Continuous	57.26 years STANDARD_DEVIATION 11.44 • n=39 Participants
Sex: Female, Male Female	18 Participants n=39 Participants
Sex: Female, Male Male	20 Participants n=39 Participants
Region of Enrollment United States	38 participants n=39 Participants

PRIMARY outcome

Timeframe: Discharge and 1 Month post surgery

Outcome measures

Outcome measures
Measure	PSD Veritas Collagen Matrix Reinforcement Arm n=38 Participants Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.	4 Participants

Adverse Events

PSD Veritas Collagen Matrix Reinforcement Arm

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PSD Veritas Collagen Matrix Reinforcement Arm n=38 participants at risk Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
Surgical and medical procedures Anastomotic Buttress Leak	7.9% 3/38 • Number of events 3
Surgical and medical procedures Bleeding	2.6% 1/38 • Number of events 1

Other adverse events

Other adverse events
Measure	PSD Veritas Collagen Matrix Reinforcement Arm n=38 participants at risk Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
Surgical and medical procedures Post operative ileus	5.3% 2/38 • Number of events 2

Additional Information

Lesa Hobright-Turner, Director of Clinical Affairs

Synovis

Phone: 651-796-7506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place