Trial Outcomes & Findings for Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh (NCT NCT02041494)

NCT ID: NCT02041494

Last Updated: 2021-04-14

Results Overview

Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 165 participants
• Primary outcome timeframe: up to 24 months after surgery
• Results posted on: 2021-04-14

Participant Flow

Adults (≥21 years of age) with a ventral hernia scheduled for an elective repair were eligible for inclusion. Recruitment and all surgical procedures were carried out from March 2014 through October 2018 at UCSF Medical Center). All participants were recruited via referral to the medical center's surgery clinics. Patients were only enrolled once.

Participant milestones

Measure	Biologic Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Overall Study STARTED	82	83
Overall Study COMPLETED	63	63
Overall Study NOT COMPLETED	19	20

Reasons for withdrawal

Measure	Biologic Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Overall Study Death	1	3
Overall Study Lost to Follow-up	2	6
Overall Study study terminated	16	11

Baseline Characteristics

Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

Baseline characteristics by cohort

Measure	Synthetic n=83 Participants Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST	Biologic n=82 Participants Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Total n=165 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	55.0 years STANDARD_DEVIATION 11.5 • n=7 Participants	55.1 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	50 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	82 participants n=7 Participants	165 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months after surgery

Population: This measure includes patients that recurred before 2 years and were not followed for 2 years, and some patients that recurred were followed for 2 years.

Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.

Outcome measures

Measure	Biologic n=63 Participants Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=64 Participants Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.	25 Participants	14 Participants

SECONDARY outcome

Timeframe: 30 days after surgery

Number of patients who experienced surgical site infections as determined by physical examination.

Outcome measures

Measure	Biologic n=82 Participants Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=83 Participants Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Number of Patients Who Experienced Surgical Site Infections.	32 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months after surgery

Quality of life will be measured using the SF-36 and the HerQLes surveys.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to two years from surgery

Population: Only patients with a surgical site occurrence were included in this outcome measure.

Number of surgical site occurrences by type.

Outcome measures

Measure	Biologic n=17 Participants Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=18 Participants Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Number of Surgical Site Occurrences Hematoma	5 surgical site occurence	—
Number of Surgical Site Occurrences Seroma	7 surgical site occurence	12 surgical site occurence
Number of Surgical Site Occurrences Wound necrosis and other	9 surgical site occurence	10 surgical site occurence

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days after surgery

Population: Only patients with other surgical complications were included in this outcome measure.

Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.

Outcome measures

Measure	Biologic n=20 Participants Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=13 Participants Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Number of Other Surgical Complications Pneumonia	4 occurence	1 occurence
Number of Other Surgical Complications Deep Vein Thrombosis/pulmonary embolism	7 occurence	5 occurence
Number of Other Surgical Complications Urinary tract infection	13 occurence	7 occurence

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months after surgery

Activity level will be measured using the Activity Assessment Scale.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months after surgery

Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data.

Outcome measures

Outcome data not reported

Adverse Events

Biologic

Serious events: 15 serious events

Other events: 27 other events

Deaths: 0 deaths

Synthetic

Serious events: 20 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Measure	Biologic n=82 participants at risk Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=83 participants at risk Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Infections and infestations deep space infection	18.3% 15/82 • Number of events 15 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	22.9% 19/83 • Number of events 19 • Adverse event data was collected throughout the duration of the study, an average of 26 months.
Infections and infestations death	0.00% 0/82 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	1.2% 1/83 • Number of events 1 • Adverse event data was collected throughout the duration of the study, an average of 26 months.

Other adverse events

Measure	Biologic n=82 participants at risk Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice	Synthetic n=83 participants at risk Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST
Infections and infestations superficial SSI	20.7% 17/82 • Number of events 17 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	10.8% 9/83 • Number of events 9 • Adverse event data was collected throughout the duration of the study, an average of 26 months.
Renal and urinary disorders urinary tract infection	13.4% 11/82 • Number of events 11 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	8.4% 7/83 • Number of events 7 • Adverse event data was collected throughout the duration of the study, an average of 26 months.
Respiratory, thoracic and mediastinal disorders pneumonia	3.7% 3/82 • Number of events 3 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	1.2% 1/83 • Number of events 1 • Adverse event data was collected throughout the duration of the study, an average of 26 months.
Blood and lymphatic system disorders DVT/pumonary embolism	7.3% 6/82 • Number of events 6 • Adverse event data was collected throughout the duration of the study, an average of 26 months.	6.0% 5/83 • Number of events 5 • Adverse event data was collected throughout the duration of the study, an average of 26 months.

Additional Information

Dr. Hobart W. Harris, Chief of General Surgery

University of California, San Francisco

Phone: (415) 514-3891

Email: hobart.harris@ucsf.edu

Results disclosure agreements

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