Trial Outcomes & Findings for Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases (NCT NCT01597128)

Results Overview

Recurrence of hernia based on physical exam and /or CT scan.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

12 months

Results posted on

2017-03-16

Participant Flow

All subjects were identified in the Minimally Invasive Surgery Clinic at the University of Kentucky Medical Center. Recruitment started in March of 2011 and ended in May of 2014

Participant milestones

Participant milestones
Measure	Flex HD Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Overall Study STARTED	18	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair	Total n=35 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 10 • n=5 Participants	58 years STANDARD_DEVIATION 12 • n=7 Participants	58 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants
Smoker	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants
BMI	34 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	34 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	34 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants
With Prior Defect	11 participants n=5 Participants	7 participants n=7 Participants	18 participants n=5 Participants
Number of Participants Who Were Employed Prior to the Hernia Repair	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Recurrence of hernia based on physical exam and /or CT scan.

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Hernia Recurrence	11 percentage of patients	12 percentage of patients

PRIMARY outcome

Timeframe: 12 months

superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence	17 percentage of patients	29 percentage of patients

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Deep Wound Infection	0 percentage of patients	6 percentage of patients

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Wound Abscess	11 percentage of patients	18 percentage of patients

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Wound Seroma	11 percentage of patients	12 percentage of patients

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Wound Cellulitis	0 percentage of patients	6 percentage of patients

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Wound Dehiscence	11 percentage of patients	0 percentage of patients

PRIMARY outcome

Timeframe: 12 months

Superficial wound infection

Outcome measures

Outcome measures
Measure	Flex HD n=18 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=17 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Wound Occurrence: Superficial Wound Infection	17 percent of patients	29 percent of patients

PRIMARY outcome

Timeframe: 12 months

Population: Patients with 12 month completion of the SF12

Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.

Outcome measures

Outcome measures
Measure	Flex HD n=15 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=10 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation	3 Normalized scores Standard Deviation 8	2 Normalized scores Standard Deviation 8

PRIMARY outcome

Timeframe: 12 months

Population: Patients with 12 month completion of the SF12

Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.

Outcome measures

Outcome measures
Measure	Flex HD n=15 Participants Human Acellular Dermal Matrix: Flex HD mesh for hernia repair	Strattice n=10 Participants Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation	0 Normalized scores Standard Deviation 12	6 Normalized scores Standard Deviation 13

Adverse Events

Flex HD

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Strattice

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flex HD n=18 participants at risk Mesh Type Flex HD: Flex HD mesh for hernia repair	Strattice n=17 participants at risk Use of a second mesh type Strattice: Strattice mash for hernia repair
Infections and infestations Abdominal Abscess	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Infections and infestations Abdominal Wound/Mesh Infection	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months

Other adverse events

Other adverse events
Measure	Flex HD n=18 participants at risk Mesh Type Flex HD: Flex HD mesh for hernia repair	Strattice n=17 participants at risk Use of a second mesh type Strattice: Strattice mash for hernia repair
Infections and infestations Abdominal Abscess	11.1% 2/18 • Number of events 2 • 24 Months	11.8% 2/17 • Number of events 2 • 24 Months
Infections and infestations Abdominal Wound Infection	16.7% 3/18 • Number of events 3 • 24 Months	11.8% 2/17 • Number of events 2 • 24 Months
Infections and infestations Wound Infection	11.1% 2/18 • Number of events 2 • 24 Months	17.6% 3/17 • Number of events 3 • 24 Months
Skin and subcutaneous tissue disorders Seroma	16.7% 3/18 • Number of events 3 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Renal and urinary disorders Renal Failure	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Infections and infestations Abdominal Compartment Syndrome	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Skin and subcutaneous tissue disorders Chronic Seroma	0.00% 0/18 • 24 Months	5.9% 1/17 • Number of events 1 • 24 Months
Skin and subcutaneous tissue disorders Wound Dehiscence	11.1% 2/18 • Number of events 2 • 24 Months	0.00% 0/17 • 24 Months
Surgical and medical procedures Hernia Recurrence	5.6% 1/18 • Number of events 1 • 24 Months	11.8% 2/17 • Number of events 2 • 24 Months
Surgical and medical procedures Parastomal Hernia	5.6% 1/18 • Number of events 1 • 24 Months	0.00% 0/17 • 24 Months

Additional Information

J. Scott Roth, M.D.

University of Kentucky Medical Center

Phone: 859-323-6346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place