Trial Outcomes & Findings for Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement (NCT NCT01325792)

Results Overview

Investigator confirmed hernia recurrence by physical examination

Recruitment status

COMPLETED

Target enrollment

104 participants

Primary outcome timeframe

at about 24 months

Results posted on

2015-12-24

104 subjects recruited from 9 sites in the US and Netherlands between March 2011 and December 2012

Participant milestones
Measure	Single-staged Open Complex Ventral Incisional Hernia Repair GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
Overall Study STARTED	104
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	17

Withdrawal data not reported

Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement

Baseline characteristics by cohort
Measure	Single-staged Open Complex Ventral Incisional Hernia Repair n=104 Participants primary or recurrent anterior abdominal wall hernia GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure
Age, Continuous	57.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Wound Classification Clean-contaminated	24 participants n=5 Participants
Wound Classification Contaminated	80 participants n=5 Participants
BMI (Body Mass Index)	27.6 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants

Timeframe: at about 24 months

Investigator confirmed hernia recurrence by physical examination

Outcome measures
Measure	Single-staged Open Complex Ventral Incisional Hernia Repair n=87 Participants primary or recurrent anterior abdominal wall hernia GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure
Hernia Recurrence Rate	17.3 % of subjects with recurrent hernia Interval 11.0 to 26.8

Timeframe: after surgery (day 1) to 24 months

Surgical site abdominal wound event rate

Outcome measures
Measure	Single-staged Open Complex Ventral Incisional Hernia Repair n=104 Participants primary or recurrent anterior abdominal wall hernia GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure
Early and Long-term Complication Rates	29.8 % of subjects with events

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events
Measure	GORE® BIO-A® Tissue Reinforcement n=104 participants at risk Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
Gastrointestinal disorders Bowel obstruction related to concomitant small bowel anastomoses during index surgery	0.96% 1/104 • Number of events 1
Gastrointestinal disorders Anastomotic leak related to concomitant bowel resection during index surgery	1.9% 2/104 • Number of events 2

Other adverse events
Measure	GORE® BIO-A® Tissue Reinforcement n=104 participants at risk Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
Infections and infestations Surgical site infection	18.3% 19/104 • Number of events 21
General disorders Surgical site seroma	5.8% 6/104 • Number of events 6

W. L. Gore & Associates, Inc., Sponsor

Phone: 800-437-8181

Principal investigator is a sponsor employee Proposed publications/public disclosures within 60 days prior to submission will be provided to sponsor for review by Investigator. Sponsor may make modifications to the proposals only as reasonably necessary to ensure the proper use of any references to itself, its trademarks, and trade names. Sponsor may correct inaccuracies in any technical specifications or descriptions of the biosynthetic material.
Publication restrictions are in place

Restriction type: OTHER